medical and science information

Health and

2010-02-04T08:36:00.000-08:00

HHS HealthBeat

(December 31, 2009)

Practicing prevention

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From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

By 2015, about 1 in 5 Americans will be between the ages of 50 and 64, which means they’ll be at a higher risk of chronic conditions such as heart disease or cancer. But a study indicates people now in this age range are not doing what they should to control their risks.

The study found only about 1 in 4 regularly take advantage of preventive services such as screenings and immunizations. And at the Centers for Disease Control and Prevention, Lynda Anderson says smoking is still a problem:

[Lynda Anderson speaks] "Only one state has met the target of 12 percent or less of adults being current smokers."

That’s Utah, at 9 percent.

The study was done by the CDC in collaboration with AARP and the American Medical Association.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

Last revised: December, 30 20

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Alert

2010-02-04T08:35:00.000-08:00

Janzen Farms Recalls Hazelnut Kernels Because of Possible Health Risks

Company Contact:
Betty Janzen,
503-868-7353

FOR IMMEDIATE RELEASE - December 24, 2009 - Janzen Farms, Dayton, Oregon is recalling hazelnut kernels because the product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditic and arthritis.

Hazelnut kernels were sold in November and December 2009 at Lenny's North, Seattle, WA and six 1 lb. bags were sold at the Sunset Produce Stand in Banks, OR.

The product is packed in 1 lb plastic bags closed with a twist-tie, with a label reading: "OREGON HAZELNUTS Product of U.S.A., JANZEN FARMS 20555 SE Webfoot Rd, Dayton, OR. Net wt. 16 oz (1 lb)".

No illnesses have been reported to date.

This recall resulted from routine sampling of product by the FDA at the company which shells the nuts and supplies the shelled hazelnuts for Janzen Farms. The supplying company has ceased the production and distribution of the product as FDA and the company continues their investigation as to what caused the problem.

Consumers who have purchased the select shelled hazelnuts packed by Janzen Farms in Dayton, Oregon are urged to return it to the place of purchase or discard it. Consumers with questions may contact Betty Janzen at 503-868-7353, Monday – Friday, between 9 a.m. to 5 p.m. Pacific Time.

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Alert

2010-02-04T08:29:00.000-08:00

FDA Warns Public of Continued Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.

The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment.”

FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.

The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA’s concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.

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Treatment

2010-02-04T08:21:00.000-08:00

HHS HealthBeat

(December 30, 2009)

Back to yoga

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From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

A study indicates yoga – done under the right circumstances – can make life better for people with chronic low back pain.

Researchers at the Boston University School of Medicine saw that in a pilot study of people in lower-income minority neighborhoods.

Those who took the 12 weekly 75-minute classes wind up with greater ability to move, and an 80 percent decrease in their pain medications, compared with those who did not do yoga.

Researcher Robert Saper cautions that some types of yoga might be bad for back pain. So he says:

[Robert Saper speaks] "For individuals who are pursuing yoga for their back pain, it’s very important that they identify a class and a teacher who has experience with this."

The study in the journal Alternative Therapies in Health and Medicine was supported by the National Institutes of Health.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

Last revised: December, 29 2009

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Alert

2010-02-02T13:07:00.000-08:00


	HEALTH RISK: HIGH

WASHINGTON, December 24, 2009 - Associated Grocers of Maine, importing firm, a Gardiner, Maine, establishment, is recalling approximately 312 pounds of ham products that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The following products are subject to recall:

16-ounce packages of "SUPER TRIM, Shurfine, IMPORTED, COOKED HAM, WATER ADDED, 98% FAT FREE."

Recommendations For People At Risk For Listeriosis

Wash hands with warm, soapy water before and after handling raw meat and poultry for at least 20 seconds. Wash cutting boards, dishes and utensils with hot, soapy water. Immediately clean spills.

Keep raw meat, fish and poultry away from other food that will not be cooked. Use separate cutting boards for raw meat, poultry and egg products and cooked foods.

Do not eat hot dogs, luncheon meats, bologna or other deli meats unless reheated until steaming hot.

Do not eat refrigerated pâté, meat spreads from a meat counter or smoked seafood found in the refrigerated section of the store. Foods that don't need refrigeration, like canned tuna and canned salmon, are safe to eat. Refrigerate after opening.

Do not drink raw (unpasteurized) milk and do not eat foods that have unpasteurized milk in them.

Do not eat salads made in the store such as ham salad, chicken salad, egg salad, tuna salad or seafood salad.

Do not eat soft cheeses such as Feta, queso blanco, queso fresco, Brie, Camembert cheeses, blue-veined cheeses and Panela unless it is labeled as made with pasteurized milk.

Use precooked or ready-to-eat food as soon as you can. Listeria can grow in the refrigerator. The refrigerator should be 40 °F or lower and the freezer 0 °F or lower. Use an appliance thermometer to check the temperature of your refrigerator.

Each package bears the establishment number "141" inside the Canadian seal of inspection and a Sell by date of "10JA24."

The ham products were produced on November 25, 2009, and distributed to retail establishments in Maine and New Hampshire.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

The problem was discovered by the Canadian Food Inspection Agency (CFIA) who notified FSIS. The CFIA notified FSIS that some of the recalled ham products had been exported to the United States. FSIS has received no reports of illnesses associated with consumption of this product.

Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Healthy people rarely contract listeriosis. However, listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weakened immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy. Individuals concerned about an illness should contact a physician.

Media and consumers with questions about the recall should contact company Vice President of Administration Cathy Callahan at (207) 588-3201.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. #

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Treatment

2010-02-02T13:03:00.000-08:00

Small Changes in Protein Chemistry Play Large Role in Huntington's Disease

In Huntington's disease, a mutated protein in the body becomes toxic to brain cells. Recent studies have demonstrated that a small region adjacent to the mutated segment plays a major role in the toxicity. Two new studies supported by the National Institutes of Health show that very slight changes to this region can eliminate signs of Huntington's disease in mice.

Researchers do not fully understand why the protein (called mutant huntingtin) is toxic, but one clue is that it accumulates in ordered clumps of fibrils, perhaps clogging up the cells' internal machinery.

"These studies shed light on the structure and biochemistry of the mutant huntingtin protein and on potentially modifiable factors that affect its toxicity," said Margaret Sutherland, Ph.D., a program director at NIH's National Institute of Neurological Disorders and Stroke (NINDS). "They reveal sites within the huntingtin protein and within broader disease pathways that could serve as targets for drug therapy."

Both studies were published online this week. One study, published in the Journal of Cell Biology, was led by Leslie Thompson, Ph.D., and Joan Steffan, Ph.D., of the University of California, Irvine. The other study, in Neuron, was led by X. William Yang, M.D., Ph.D., of the University of California, Los Angeles in collaboration with Ron Wetzel, Ph.D., of the University of Pittsburgh School of Medicine.

Huntington's disease is inherited, and usually strikes in middle age, producing uncontrollable movements of the legs and arms, a loss of muscle coordination, and changes in personality and intellect. It is inexorably progressive and leads to death of affected persons usually within 20 years after symptoms first appear. Individuals with the disease carry mutations that affect the huntingtin protein. The mutations involve a triple repeat DNA sequence, a type of genetic miscue similarly found in Friedreich's ataxia, Kennedy's disease, fragile X syndrome, and other neurodegenerative disorders.

The normal huntingtin protein consists of about 3,150 amino acids (which are the building blocks for all proteins). In individuals with Huntington�s disease, the mutated protein contains an abnormally long string of a single amino acid repeat; lengthier chains are associated with worse symptoms and earlier onset of the disease. In recent years, however, researchers have begun looking at the effects of other, nearby amino acids in this large protein — and in particular, biochemical changes to those amino acids.

In their study, Drs. Steffan and Thompson investigated how a process called phosphorylation affects huntingtin. Phosphorylation is the attachment of chemical tags, known as phosphates, onto the amino acids in a protein. The process occurs naturally and is a way of marking proteins for destruction by cellular waste handling systems. The researchers liken it to putting a sign on a pile of junk that tells the garbage collectors to take it away. Their study shows that phosphorylation of just two amino acids, located at one end of huntingtin, targets the protein for destruction and protects against the toxic effects of the mutant protein.

"Clearance of mutant huntingtin is likely regulated at many levels, but our data establish that these two amino acids are critical," Dr. Steffan said.

Could boosting phosphorylation of those two amino acids reduce the buildup of huntingtin and improve symptoms of the disease? In parallel with the UC Irvine research, Dr. Yang and his team at UCLA were asking that question using an animal model of Huntington�s disease. Previously, Dr. Yang had created mice that carry the mutant huntingtin gene. These mice develop symptoms reminiscent of Huntington�s disease in humans, including poor coordination, mental changes such as increased anxiety, loss of brain tissue, and accumulation of clumps of huntingtin in brain cells.

Through further genetic engineering, Dr. Yang altered the same two critical amino acids at the end of the mutant huntingtin protein to either mimic phosphorylation (phosphomimetic) or resist it (phosphoresistant). Mice with the phosphoresistant version of the protein developed symptoms of Huntington's, but mice with the phosphomimetic version remained free of symptoms and huntingtin clumps up to one year.

Meanwhile, test tube experiments by Dr. Wetzel's group in Pittsburgh showed that phosphomimetic modification of a huntingtin fragment reduced its tendency to form clumps. Together, data from the mouse and test tube experiments provide strong support for the idea that phosphorylation acts as a molecular switch to alter clumping of the mutant protein, the researchers said.

The nearly complete lack of any signs of disease in the phosphomimetic Huntington mice may point toward new strategies to treat the disorder someday. Dr. Yang said, "Drugs that enhance or mimic the effects of phosphorylation may help to detoxify the mutant huntingtin protein."

If such drugs could be developed, Drs. Steffan and Thompson theorize, they would likely be most effective at early stages of the disease, but less so at later stages, when the clearance machinery appears to run down. Dr. Yang said he plans to examine older mice carrying the phosphomimetic version of mutant huntingtin to determine how long they are protected from the disease.

The researchers received major funding from NINDS, with additional support from the National Institute on Aging, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of General Medical Sciences. Several nonprofit foundations also contributed to the research, including the Hereditary Disease Foundation, the Fox Family Foundation and CHDI Inc.

Co-authors of the Journal of Cell Biology study included J. Lawrence Marsh, Ph.D. and Lan Huang, Ph.D., at UC Irvine; Ana Maria Cuervo, M.D., Ph.D., at Albert Einstein College of Medicine, New York City; Donald C. Lo, Ph.D. at Duke University, Durham, N.C.; Paul H. Patterson, Ph.D., at California Institute of Technology, Pasadena; and Steven Finkbeiner, M.D., Ph.D., at the University of California, San Francisco.

Co-authors of the Neuron study included Xiaofeng Gu, M.D., Ph.D., and Erin Greiner at UCLA; Rakesh Mishra and Ravindra Kodali, Ph.D., at the University of Pittsburgh; Alex Osmand, Ph.D., at the University of Tennessee, Knoxville; and Dr. Finkbeiner at UCSF.

NINDS (www.ninds.nih.gov) is the nation�s primary supporter of biomedical research on the brain and nervous system. NIA (www.nia.nih.gov) leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people. NICHD (www.nichd.nih.gov) sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. NIGMS (www.nigms.nih.gov) supports basic biomedical research that is the foundation for advances in disease diagnosis, treatment and prevention.

For more information about Huntington's disease, visit http://www.ninds.nih.gov/disorders/huntington/huntington.htm.

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Health and

2010-02-02T12:59:00.000-08:00

Neighborhood Food Options Linked to Obesity in New York City

Access to stores that sell healthy foods may be a crucial factor in fighting obesity, according to a new study.

About two-thirds of adults nationwide are overweight, and almost one-third are obese. Much attention has been focused on the role of fast food and soft drinks in obesity. A growing body of research suggests that the "built environment" also plays a role—that is, access to stores that sell healthy foods and to resources that support physical activity, such as green spaces.

Researchers at Columbia University led by Dr. Andrew Rundle set out to explore how the food environment relates to weight in New York City, an area with a variety of people and neighborhoods. The researchers tapped the New York Cancer Project for data on height, weight, age, race/ethnicity, gender, income and education for over 13,000 residents of New York City.

The researchers defined a person's neighborhood as a half-mile around his or her home. To form a picture of these areas, they compiled data from several sources, incorporating population information, bus and subway stops, land use information and neighborhood food establishments. The team then analyzed any possible associations between a person's food environment and his or her BMI-a ratio of weight to height often used to estimate body fat. The analysis was supported by NIH's National Institute of Environmental Health Sciences (NIEHS).

The team reported in the March 2009 issue of Environmental Health Perspectives that they found 1 significant association between the food environment and BMI: access to healthy food outlets such as supermarkets, natural food stores and fruit and vegetable markets.

Surprisingly, the researchers didn't uncover an association with unhealthy food outlets such as fast-food restaurants, convenience stores, pizzerias, bakeries and candy and nut stores. However, they note that the lack of association may just reflect the fact that virtually all New York City neighborhoods provide many opportunities for people to eat poorly. Almost 99% of the people in the study lived within a half-mile of an unhealthy food outlet. By contrast, only 82% lived within a half-mile of a healthy food outlet. There were more unhealthy food choices for most people as well, with an average of over 7 unhealthy food outlets for every healthy outlet.

The researchers note that this finding doesn't prove that healthy food choices are responsible for lowering BMI. People who prefer healthy foods may tend to move into neighborhoods with more healthy food outlets. Retailers selling healthy foods, in turn, open where they think the population will be most receptive to their products.

While these results need to be confirmed by future studies, they suggest that increasing access to healthy food outlets could help combat the obesity epidemic more effectively than limiting unhealthy food. Many communities around the country have begun initiatives to promote access to supermarkets, farmers markets, and fruit and vegetable stands. "I see a role for follow-up studies to examine changes in diet and obesity rates in neighborhoods where new supermarkets or produce stores open," Rundle says.

—by Harirson Wein, Ph.D.

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Health and

2010-02-02T12:57:00.000-08:00

Vitamin C May Reduce Risk of Gout

A new study has linked higher vitamin C intake with a lower risk of gout. Vitamin C supplements, the results imply, may help to prevent gout.

Nearly 3 million adults nationwide are estimated to have gout. The condition develops when excess uric acid in the blood begins to form crystals. These crystals then accumulate in joints to cause swelling and pain. Gout often first affects the joints of the big toe, but many other joints can also be involved. Left untreated over time, gout can permanently damage affected joints.

Recent studies have found that higher vitamin C intake reduces uric acid levels in blood. Whether this ultimately affects the risk of gout, however, has been unknown. A research team led by Dr. Hyon K. Choi of the University of British Columbia (now at the Boston University School of Medicine) set out to examine the relationship between vitamin C intake and gout. Their work was supported by grants from several NIH institutes and TAP Pharmaceuticals.

The researchers studied data gathered between 1986 and 2006 by the ongoing Health Professionals Follow-up Study. The study asked male health professionals to fill out a dietary questionnaire every 4 years. From these, the researchers calculated the men’s vitamin C intake, adding in vitamin C from supplements. Every 2 years, the men also recorded whether they had received a doctor’s diagnosis of gout. The researchers were thus able to compare vitamin C intake with the incidence of gout in almost 47,000 men who didn’t have gout when the study began.

By 2006, gout had developed in 1,317 of the men. The results, published in the March 9, 2009, issue of Archives of Internal Medicine, showed that men who had the highest vitamin C intake—1,500 milligrams or higher per day—had a 45% lower risk of gout than those with the lowest daily intake—less than 250 milligrams per day.

When the researchers focused on vitamin C supplements, they found that the men who took 1,000-1,499 milligrams per day had a 34% lower risk of gout than men who didn’t take any vitamin C supplements. Those who took 1,500 milligrams per day had a 45% lower risk than those who didn’t take any.

These associations held independent of dietary and other known risk factors for gout, including body mass index (a ratio of weight to height), age, hypertension, diuretic use, alcohol use and chronic renal failure. The results support the idea that vitamin C has a protective effect against gout. The researchers believe it may act by helping the kidneys clear uric acid from blood. The vitamin might also help protect against the inflammation caused by gout.

The protective effect of vitamin C against gout still needs to be confirmed in a controlled clinical trial. The recommended daily intake for vitamin C, set by the Food and Nutrition Board at the National Academies’ Institute of Medicine, is currently 90 milligrams per day for men. High doses of vitamin C can cause side effects, including stomach upset and diarrhea, so talk to your doctor if you’re considering taking vitamin C supplements to prevent gout.

—by Harrison Wein, Ph.D.

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Drugs

2010-02-02T12:54:00.000-08:00

Genetic Tests Help Optimize Doses of Blood-Thinning Drug

Genetic tests can help doctors fine-tune the dosing of the widely prescribed blood-thinner warfarin for individual patients, according to a new study. The research may ultimately help patients avoid the life-threatening dangers of too-high or too-low doses of the drug.

Each year about 2 million Americans with certain heart conditions or other risk factors start taking warfarin, also known as Coumadin. It's often prescribed to prevent blood clots that can lead to heart attack, stroke or even death. But determining how much warfarin each patient needs can be difficult. The ideal dosage varies widely, with some patients needing about 10 times more than others. Yet finding the appropriate dosing is crucial. Too much can lead to excess bleeding, and too little can fail to prevent dangerous blood clots.

Scientists already knew that variations in 2 genes can influence warfarin's effectiveness. One gene, called CYP2C9, deactivates warfarin. The other, VKORC1, activates vitamin K, which is essential for blood clotting. However, it's been unclear whether these 2 genes could help doctors predict the ideal warfarin dosage for a wide range of patients with race, ethnicity or other genetic differences.

To investigate, researchers from 9 countries pooled their data on more than 5,000 people taking stable doses of warfarin. The team first analyzed data from about 4,000 of the patients, including demographic information like age, gender and race; CYP2C9 and VKORC1 variants; and initial, as well as optimized, warfarin dosages. Each patient’s optimal dosing had already been determined by gradually adjusting the doses based on blood tests. The study was funded in part by NIH’s National Institute of General Medical Sciences (NIGMS) and 3 other NIH components.

Based on their analysis, the scientists developed a mathematical formula, or algorithm, that uses both clinical and genetic data to predict the ideal warfarin dosage for each patient. They also made dose predictions using a different algorithm based only on clinical information. To test the validity of the 2 algorithms, the researchers then analyzed how well their computational predictions matched the actual, clinically derived optimal dosages of warfarin for the remaining 1,000 patients.

The results—described in the February 19, 2009, New England Journal of Medicine—showed that when genetic information was included, the predictions of ideal dosages were more accurate, especially for patients at the low or high ends of the dosing range. This is important because nearly half of those on warfarin are at the extremes of the range, and these patients are often at greatest risk for excessive bleeding or clotting.

"It appears that up to 46% of people will require a warfarin dose that is significantly higher or lower than average," says study co-author Dr. Russ Altman of the Stanford University School of Medicine. "We're hoping that our research will help clinicians get it right on the first try."

NIH’s National Heart, Lung and Blood Institute (NHLBI) is now launching a large clinical trial to evaluate a gene-based strategy for selecting initial warfarin doses based on blood test results. The trial, scheduled to begin in April 2009, will enroll 1,200 participants of diverse backgrounds and ethnicities at 12 clinical sites.

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Alert

2010-01-31T05:58:00.000-08:00

Mountain Man Nut & Fruit Co.® Announces Voluntary Recall of Hazelnut

Company Contact:
Mike Conner,
303-841-4041 ext. 306

FOR IMMEDIATE RELEASE - December 18, 2009 - Parker, Colorado – Mountain Man Nut & Fruit Co. is voluntarily recalling select products containing shelled hazelnuts (filberts).

Mountain Man is initiating this recall in conjunction with the recall from Kunze Fams due to the fact that raw hazelnuts could have been exposed to salmonella and become contaminated. During routine inspection of the hazelnut shelling facility one salmonella test came back positive. In the interest of the safety of our customers, Mountain Man is requesting that customers return any of the lot codes below to their place of purchase for replacement or refund.

Mountain Man has not received any complaints of consumer illness associated with these products. This is strictly a precautionary recall to insure the safety of our customers.

All of the below is product that would have been manufactured and packaged since November 1, 2009 and December 17, 2009. Product purchased before or after these dates should not be affected by this recall.

Product Name	Lot Codes Affected
Filberts	289091A, 299091A
Natural Mixed Nuts	32009, 33809
Fancy Mixed Nuts – 8 & 16 oz bags	30909, 31309, 31709, 32009 32309, 32909, 33509, 33709 34209, 34309, 34809, 34909 35009
Choice Mixed Nuts – 16 oz bags	31309, 32709, 33609, 34909
Dry Roast Mixed Nuts – 16 oz bags	30909
Sweet Simplicity™ Trail Mix	32909
Mountain Jubilee® Trail Mix – 8 & 16 oz bags	31309, 32409, 33709, 34909
Cinnamon Almond Appleanche™ Trail Mix	31009
Fancy Mixed Nut Gift Packs – 1.75 lb	All product except 35009
Fancy Mixed Nut Gift Packs – 1 lb	All product except 35009

Product with these lot codes could also be present as a component in some of our gift baskets, including the 12 Tastes Basket, Bounty Basket and Half-Pound Sampler Basket. Because all of the products in a gift basket are individually packaged, only the above named products would be subject to this recall. Customers who receive these baskets can bring any of the above products to a distributor or store to receive a replacement product.

The above affected product has only been distributed through Mountain Man Distributors, Retail Stores and directly through our website.

Also note that any product sold in the State of Oregon is not affected by this recall.

Consumers who have purchased the recalled products should return them to their place of purchase for replacement product or a refund. Questions may be directed to the company at 1-800-225-0045, Monday-Friday between the hours of 7:00 AM and 4:30 PM MST.

About Salmonella

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s Website at http://www.cdc.gov.

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Treatment

2010-01-31T05:51:00.000-08:00

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Accelerated approval process used in vaccine approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

“As people grow older, their immune systems typically become weaker,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza.”

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

For more information

FDA Web Page on Vaccines, Blood & Biologics
http://www.fda.gov/BiologicsBloodVaccines/default.htm.

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Treatment

2010-01-31T05:45:00.000-08:00

HHS HealthBeat

(December 24, 2009)

When do you need more help?

Listen to Tip

Interested?
Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

Most of the time, the best thing to do for the flu is treat symptoms and wait it out. Other times, that’s not enough, and you may need to seek more help.

But hospitals want to focus on people with greatest need. So how can you tell when to seek medical help?

At the Centers for Disease Control and Prevention, Dr. Joe Bresee:

[Dr. Joe Bresee speaks] "People with the following symptoms should call for emergency medical help immediately:

Signs of breathing or heart problems, like chest pain, shortness of breath, bluish or purplish lips
Signs of dehydration, like yellowish or leathery skin, decreased urination, or confusion. Sometimes, children will have no tears when they cry."

Common symptoms of seasonal and H1N1 flu include fever, cough, sore throat, runny or stuffy nose, body aches, headaches, chills, and tiredness.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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Health and

2010-01-31T05:38:00.000-08:00

HHS HealthBeat

(December 22, 2009)

Yoga backs

Listen to Tip

Interested?
Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

A study indicates a form of yoga that stresses body alignment can help some people with lower back pain.

Kimberly Williams of West Virginia University examined that in people who did two 90-minute classes a week, and who were encouraged to do 30 minutes a day on other days, for 24 weeks. Williams says they reported 29 percent less disability, 42 percent less pain and 45 percent less depression than people who did not do yoga.

Her recommendation:

[Kimberly Williams speaks] "Get involved in active recovery, find a highly qualified certified teacher of yoga who has experience helping people with chronic low back pain, and I’d also encourage them to get their doctors involved."

The study in the journal Spine was supported by the National Institutes of Health.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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Science

2010-01-31T05:36:00.000-08:00

HHS HealthBeat

(December 23, 2009)

Kids without rotavirus

Listen to Tip

Interested?
Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

At one time, rotavirus was something just about every kid had by the age of 5 years. It’s still that way in much of the world. But since 2006, there are vaccines, so we can prevent rotavirus’ diarrhea and dehydration. And researchers say the vaccines are making a difference in America.

At the Centers for Disease Control and Prevention, Dr. Jennifer Cortes:

[Dr. Jennifer Cortes speaks] "We’ve seen some pretty impressive declines in rotavirus disease. Some data shows up to 60 percent decreases in the number of rotavirus cases."

That’s important, because rotavirus can, in the worst cases, lead to hospitalization and possibly death.

Babies under 6 months can get the vaccines – there are two types, and both are liquids.

The study is in the Morbidity and Mortality Weekly Report.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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Treatment

2010-01-29T09:06:00.000-08:00

Too Little Vitamin D May Worsen Asthma

Low levels may also hinder response to steroid treatment, study finds.

By Steven Reinberg
HealthDay Reporter

THURSDAY, Jan. 28 (HealthDay News) -- People with asthma who have low levels of vitamin D fare worse than those with high levels of the "sunshine" vitamin, a new study finds.

Researchers found that asthmatics with high vitamin D levels have better lung function and respond better to treatment than asthmatics with low vitamin D levels do.

"Our findings suggest that low vitamin D levels are associated with worse asthma," said lead researcher Dr. E. Rand Sutherland, from the division of pulmonary and critical care medicine at National Jewish Health in Denver.

In addition, vitamin D levels predict how well "somebody is going to respond to steroidal asthma medications," he said. "It may be that vitamin D is acting as a modifier of the immune system or a modifier of steroid response in ways that are relevant to people with asthma."

The report is published in the Jan. 28 online edition of the American Journal of Respiratory and Critical Care Medicine.

For the study, Sutherland's team took the vitamin D levels of 54 asthmatics and assessed lung function, airway hyper-responsiveness, which is the prevalence of airway constriction, and response to steroid treatment.

People with low levels of vitamin D in their blood did worse on the tests that evaluated lung function and airway hyper-responsiveness, the researchers found.

In those with vitamin levels below 30 nanograms per milliliter (ng/ml), airway hyper-responsiveness almost doubled, compared to those with more D in their blood.

Low vitamin D levels were also associated with a worse response to steroid therapy and increased production of the pro-inflammatory cytokine, TNF-alpha. This raises the possibility that low vitamin D levels are tied to increased inflammation of the airways.

The heaviest participants had the lowest levels of vitamin D, the study noted. Asthma is associated with obesity, and this (lack of vitamin D) may be a factor linking the two conditions, Sutherland said.

"There is a potential that restoring normal vitamin D levels in people with asthma may help improve their asthma," Sutherland said.

But whether vitamin D supplements will help asthmatics isn't known, he added.

Current recommendations for vitamin D supplements for adults is 400 IU to 600 IU, depending on age, according to the U.S. National Institutes of Health.

"There is likely little harm in adhering to those guidelines," Sutherland said.

The Institute of Medicine is currently evaluating these levels and expects to announce new guidelines in May.

Sunlight, fatty fish and fish oils are also sources of vitamin D.

Dr. Michael F. Holick, director of the Vitamin D, Skin and Bone Research Laboratory at Boston University School of Medicine, called this "a very nice study that confirms previous observations that vitamin D enhances lung function."

"It is also known that glucocorticoids [steroids] increase the destruction of vitamin D, thus making patients with asthma at higher risk for vitamin D deficiency, which in turn decreases lung function and makes their disease worse," he said.

Holick thinks most people, asthmatic or not, get too little D and should take supplements.

"It's pretty clear that you need a minimum of 1,400 and up to 2,000 IU a day, and if you are obese, you probably need at least one and a half to two times as much, because the fat sequesters the vitamin D," Holick said. "We now recognize that you can take up to 10,000 IUs a day and not worry about any untoward toxicity."

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Cancer

2010-01-29T09:04:00.000-08:00

Symptoms Alone Don't Spot

Ovarian Cancer Early

Researcher notes bloating, stomach pain, fatigue also point to less serious diseases

By Jennifer Thomas
HealthDay Reporter

THURSDAY, Jan. 28 (HealthDay News) -- Relying on symptoms alone to identify women who have ovarian cancer isn't very effective at catching the disease early, a new study indicates.

Research shows that women with ovarian cancer are much more likely than healthy women to report symptoms such as abdominal pain, bloating, feeling full quickly after eating and urinary urgency, especially if the symptoms are relatively new and persistent, said study author Mary Anne Rossing, a member of the Program in Epidemiology at Fred Hutchinson Cancer Research Center in Seattle.

But because ovarian cancer is fairly rare, while the symptoms are relatively common and possibly explained by less serious conditions, the ability to predict who has cancer based on symptoms alone is limited, Rossing said.

Researchers found that for every 100 women in the general population whose symptoms matched those in a widely accepted ovarian cancer symptom index, only one would actually have early-stage ovarian cancer.

"The rarity of ovarian cancer in the general population results in the positive predictive value of these symptoms in detecting ovarian cancer as being quite low," Rossing said. The disease strikes about one in 72 women.

The study is published in the Jan. 28 online issue of the Journal of the National Cancer Institute.

Finding ways to detect early-stage ovarian cancer is an ongoing challenge, said Cara Tenenbuam, vice president of policy and external affairs for the Ovarian Cancer National Alliance.

Ovarian cancer sometimes is found during a pelvic exam, but tumors are often too deep within the body for doctors to detect. In addition, the symptoms of ovarian cancer are often missed or misdiagnosed as other less serious conditions, including menopause, lactose intolerance, irritable bowel syndrome or even depression, Tenenbaum said

While nine of 10 women whose ovarian cancer is caught early are alive five years after diagnosis, only about 20 percent of ovarian cancers are found at their early stage, according to the American Cancer Society.

To address this, in 2007, three major cancer organizations -- the American Cancer Society, the Gynecologic Cancer Foundation and the Society of Gynecologic Oncologists -- released a consensus statement that included a constellation of symptoms women and their doctors should be aware of, including swelling of the stomach or bloating, pelvic pressure or stomach pain and trouble eating.

Rossing and her colleagues interviewed 812 women aged 35 to 74 who had epithelial ovarian cancer, the most common type of ovarian cancer, about their symptoms during the year leading up to diagnosis and compared them to 1,313 who didn't have cancer.

Women who were diagnosed with cancer were 10 times more likely to experience the symptoms than women without cancer, according to the study. Among patients with early-stage disease, about 27 percent experienced the symptoms for at least five months before diagnosis.

Yet the symptoms aren't much use in identifying cases of ovarian cancer in the general population because in 99 out of 100 cases, a women with the symptoms would not have ovarian cancer, Rossing said.

"We need to understand more about the benefits and risks for women who receive evaluations for ovarian cancer because of these symptoms," Rossing said. "Risks may include the worry and expense of unnecessary testing, ultrasound and even unnecessary surgery."

Last year, 21,550 new cases of ovarian cancer were diagnosed among U.S. women; 14,600 deaths were attributed to the disease.

In the absence of more precise screening techniques, Tenenbaum said women and their doctors should be aware of possible signs of ovarian cancer, and women should not hesitate to see their doctors if their symptoms are persistent or are clearly not how they usually feel.

"We talk a lot about symptom awareness, but what this study shows is we still need a reliable early detection test," Tenenbaum said. "The symptoms index is the best we have right now for early detection. You need to know what's normal for you. If it's new for you and you're not feeling good, we want you to have good access to medical care and to avail yourself of it."

Meanwhile, scientists continue to experiment with better detection methods. According to a study in the February issue of the American Journal of Roentgenology, researchers are working on developing better early-stage cancer detection through the use of contrast-enhanced ultrasound combined with blood tests that look for tumor biomarkers.

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Science

2010-01-29T08:32:00.000-08:00

Your Body Moves Through

Time With Your Mind

Posture seems to reflect thoughts of past or future, study finds.

THURSDAY, Jan. 28 (HealthDay News) -- When people think back to the past or look toward the future, their body language reflects their sense of time travel, a new study suggests.

Researchers at the University of Aberdeen fitted subjects with motion sensors and asked them to imagine events in the future or the past. The bodies of those who thought about the future actually moved forward. Those who thought about the past swayed backward.

The findings appear online in the journal Psychological Science.

"The embodiment of time and space yields an overt behavioral marker of an otherwise invisible mental operation," the researchers wrote.

More information

The National Institute of Neurological Disorders and Stroke has more on the brain.

(SOURCE: Association for Psychological Science, news release, January 2010)

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Drugs

2010-01-29T08:14:00.000-08:00

Approved Drug Products with

Therapeutic Equivalence

Evaluations (Orange Book)

The Orange Book data files are current through December 2009. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files. However, if you detect an error or discrepancy in drug data, please send a brief description of the data problem to the following e-mail address: DRUGPRODUCTS@CDER.FDA.GOV.

General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Drug Information Branch at the following e-mail account: DRUGINFO@FDA.HHS.GOV.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information Staff at:

Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500

The CDER Freedom of Information Office Electronic Reading Room provides background information about the FOI process.

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Alert

2010-01-29T08:12:00.000-08:00

Teva Animal Health, Inc. expands a voluntary nationwide recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

Contact:
Denise Bradley
Tel: 215-591-8974

FOR IMMEDIATE RELEASE -- December 21, 2009 - Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

Ketamine Hydrochloride is a rapid acting, non-narcotic, non-barbiturate agent for anesthetic use in cats and for restraint in subhuman primates. This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

Consumers with questions may contact 800-759-3664 from 8:00am – 5:00pm CST Monday-Friday.

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Science

2010-01-27T07:57:00.000-08:00

NIH-Funded Study Unveils Potential Genetic Links to Lung Disease Risk

A new study involving data from more than 20,000 individuals has uncovered several DNA sequences linked to impaired pulmonary function. The research, an analysis that combined the results of several smaller studies, provides insight into the mechanisms involved in reaching full lung capacity. The findings may ultimately lead to better understanding of lung function and diseases like asthma and chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the United States.

"We have known for a while that genetic factors put some people at risk for lower lung function — a factor in COPD and a risk for early mortality. But, we did not know which specific genetic regions were involved," said Stephanie London, M.D., Dr.P.H., senior investigator at the National Institute of Environmental Health Sciences (NIEHS), part of National Institutes of Health (NIH), and a senior author on the paper. "These findings point to specific gene regions."

Impaired lung function is a hallmark of COPD and other lung diseases. But it is also linked to mortality from a wide range of other diseases, including cardiovascular disease and cancer. So knowing some of the genes involved is a first step toward understanding the relationship between lung function and mortality, as well as developing new interventions to manage lung diseases.

"Leveraging our investment in collecting these samples has led to new findings and will help focus future research efforts," said James P. Kiley, Ph.D., director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute (NHLBI).

To conduct the analysis that is published online in the Dec. 13, 2009 issue of Nature Genetics, the researchers used data from the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium. CHARGE is an ongoing study — a group of groups — that combines genome-wide association study (GWAS) results from several population-based studies. Pooling data from many studies gives much greater power to find the specific genes involved than looking at any one study alone.

The GWAS approach involves measuring hundreds of thousands of genetic variants, in thousands of individuals, in hopes of finding novel genetic variations associated with specific diseases or conditions.

This meta-analysis provided data from more than 20,000 participants. The individual studies included three US-based population studies supported by the NHLBI — the Artherosclerosis Risk in Communities, the Cardiovascular Health Study, and the Framingham Heart Study � and the Rotterdam Study in the Netherlands.

The researchers focused on finding genetic commonalities in DNA that lead to some people having lower lung function than others of the same age, gender, race, size and smoking history.

One way researchers determine airflow obstruction is by using a machine called a spirometer to measure how much air a person breathes in and out, as well as how fast it is blown out, or expired. Spirometry is an important tool used to diagnose asthma, pulmonary fibrosis, cystic fibrosis, COPD, as well as the impact of environmental exposure on lung health. In disease, the ratio between forced expiratory volume (FEV1) and forced vital capacity (FVC) � an indicator of airflow obstruction � is abnormally low.

"This is a beautiful example of how modern genomic approaches can unearth valuable new insights from previous research," said NIEHS Director Linda Birnbaum, Ph.D. "It sets us on a course for learning much more about how lung diseases develop and how environmental triggers like smoking and air pollution work in combination with genes."

For more information about lung diseases, visit http://www.nhlbi.nih.gov/health/public/lung/index.htm.

The NIEHS supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, visit our Web site at http://www.niehs.nih.gov.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, and sleep disorders.

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Health and

2010-01-27T07:54:00.000-08:00

Teen Methamphetamine Use, Cigarette Smoking at Lowest Levels in NIDA's 2009 Monitoring the Future Survey

Downward Marijuana Trend Stalls and Prescription Drug Abuse Worrisome

WASHINGTON � Methamphetamine use among teens appears to have dropped significantly in recent years, according to NIDA's annual Monitoring the Future (MTF) survey, released today at a news conference at the National Press Club in Washington. However, declines in marijuana use have stalled, and prescription drug abuse remains high, the survey reported.

The Monitoring the Future survey is a series of classroom surveys of eighth, 10th, and 12th graders conducted by researchers at the University of Michigan under a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

The number of high school seniors reporting they used methamphetamine in the past year is now at only 1.2 percent — the lowest since questions about methamphetamine were added to the survey in 1999, when it was reported at 4.7 percent. In addition, the proportion of 10th graders reporting that crystal meth was easy to obtain has dropped to 14 percent, down from 19.5 percent five years ago.

"We are encouraged by the reduction of methamphetamine use, but we know that each new generation of teens brings unique prevention and education challenges," said NIH Director Francis S. Collins M.D., Ph.D. "What makes the Monitoring the Future survey such a valuable public health tool is that it not only helps us identify where our prevention efforts have been successful, it also helps us identify new trends in drug use and attitudes that need more attention."

The report says cigarette smoking was at the lowest point in the survey's history on all measures for eighth, 10th and 12th graders. For example, only 2.7 percent of eighth graders describe themselves as daily smokers, down from a peak rate of 10.4 percent in 1996. Similarly, 11.2 percent of high school seniors say they smoke daily, less than half of the 24.6 percent rate in 1997. However, one area of concern is the rate of smokeless tobacco use. The rate of 10th graders using smokeless tobacco in the past month is 6.5 percent, up from last year and the same as it was in 1999.

"The decline in cigarette smoking translates to longer, healthier lives for today's young people," said NIDA Director Dr. Nora Volkow. "And while it is disheartening that smokeless tobacco use is up again, the survey is telling us where to focus prevention efforts."

Marijuana use across the three grades has shown a consistent downward trend since the mid-1990s, however, the decline has stalled, with rates at the same level as five years ago. In the 2009 survey, reported past year marijuana use was about the same as the previous year: 32.8 percent of 12th graders, 26.7 percent of 10th graders, and 11.8 percent of eighth graders. However, marijuana use is still down significantly from its peak in the mid-late 1990s.

The MTF survey also measures teen attitudes about drugs, including perceived harmfulness, perceived availability, and disapproval, which are often harbingers of abuse. For example, the percentage of eighth graders who view occasional marijuana smoking as potentially harmful is down to 44.8 percent, compared to 48.1 percent last year and 57.9 percent in 1991.

"The 2009 Monitoring the Future survey is a warning sign, and the continued erosion in youth attitudes and behavior toward substance abuse should give pause to all parents and policymakers," said Director Gil Kerlikowske, of the White House Office of National Drug Control Policy. "Considering the troublesome data from other national and local surveys, these latest data confirm that we must redouble our efforts to implement a comprehensive, evidence-based approach to preventing and treating drug use."

The data on some illicit drugs is encouraging. Past year use of cocaine decreased to 3.4 percent from 4.4 percent in 2008 among 12th graders, and past year use of hallucinogens also fell among high school seniors to 4.7 percent, down from last year�s 5.9 percent rate and significantly lower than its 2001 peak of 9.1 percent.

For the first time this year the survey also measured 12th graders' use of the hallucinogenic salvia leaf, with 5.7 percent of high school seniors reporting past year use.

Perceived harmfulness of LSD, amphetamines, sedatives/barbiturates, heroin and cocaine have all increased among 12th graders, and the perceived availability of many illicit drugs has dropped considerably. For example, 33.9 percent of 12th graders reported this year that it is easy to get powder cocaine, down from 38.9 percent just a year ago. Similarly, 35.1 percent of 12th graders said ecstasy is easy to obtain, compared to 41.9 percent last year.

The 2009 MTF survey indicates a continuing high rate of non-medical use of prescription drugs and cough syrup among teens. Seven of the top 10 drugs abused by 12th graders in the year prior to the survey were prescribed or, purchased over the counter.

Nearly 1 in 10 high school seniors reported past year non-medical use of Vicodin, and 1 in 20 reported abusing Oxycontin, also a powerful opioid painkiller. Non-medical use of these painkillers has increased among 10th graders in the past five years.

For the first time this year the survey measured the non-medical use of Adderall, a stimulant commonly prescribed to treat ADHD. The survey reported that more than 5 percent of 10th and 12th graders reported non-medical use of the drug in the past year.

In addition, the survey recently started measuring how teens obtain the prescription drugs they took for non-medical use. Nineteen percent of 12th graders reported they got their drugs by a doctor's prescription, and 8 percent reported buying them from a dealer. However, the vast majority — 66 percent — said they got the drugs from a friend or relative. Of these, 12 percent reported they "took" them; 21 percent reported "buying" them and 33 percent said they were "given" the drugs. Internet purchases do not appear to be a major source of drugs for this age group.

Researchers also report a softening of attitudes in some alcohol measures. Fewer 10th graders viewed weekend binge drinking (five or more drinks once or twice each weekend) as harmful, and fewer high school seniors disapproved of having one or two drinks every day. Alcohol use however, has decreased in the past five years across all three grades.

Overall, 46,097 students from 389 public and private schools in the eighth, 10th, and 12th grades participated in this year's survey. Since 1975, the MTF survey has measured drug, alcohol, and cigarette use and related attitudes in 12th graders nationwide; eighth and 10th graders were added to the survey in 1991. Survey participants report their drug use behaviors across three time periods: lifetime, past year, and past month. The survey has been conducted since its inception by a team of investigators at the University of Michigan, led by NIDA grantee Dr. Lloyd Johnston. Additional information on the MTF, as well as comments from Dr. Volkow can be found at www.drugabuse.gov.

MTF is one of three major surveys sponsored by the U.S Department of Health and Human Services that provide data on substance use among youth, along with the National Survey on Drug Use and Health and the Youth Risk Behavior Survey. The MTF Web site is http://monitoringthefuture.org. More information on MTF can be found at http://www.hhs.gov/news; or http://www.whitehousedrugpolicy.gov.

The National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration, is the primary source of statistical information on substance use in the U.S. population 12 years of age and older. More information is available at http://www.drugabusestatistics.samhsa.gov.

The Youth Risk Behavior Survey, part of HHS' Centers for Disease Control and Prevention's Youth Risk Behavior Surveillance System, is a school-based survey that collects data from students in grades 9-12. The survey includes questions on a wide variety of health-related risk behaviors, including substance abuse.

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Drugs

2010-01-27T07:43:00.000-08:00

Drug for Multiple Myeloma Demonstrated to Significantly Extend Disease-Free Survival

Initial results from a large, randomized clinical trial for patients with multiple myeloma, a cancer of the blood and bone marrow, showed that patients who received the oral drug lenalidomide (Revlimid, also known as CC-5013) following a blood stem cell transplant had their cancer kept in check longer than patients who received a placebo. The clinical trial, for patients ages 18 to 70, was sponsored by the National Cancer Institute (NCI), and conducted by a network of researchers led by the Cancer and Leukemia Group B (CALGB) in collaboration with the Eastern Cooperative Oncology Group (ECOG) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The BMT CTN is co-sponsored by NCI and the National Heart, Lung, and Blood Institute, both parts of the National Institutes of Health.

The independent data and safety monitoring committee overseeing the trial (known as CALGB-100104) found that the study demonstrated a longer time before the cancer progressed following autologous blood stem cell transplantation for those patients on the study drug than those on placebo and so the trial was stopped early. Autologous blood stem cell transplantation is a procedure in which a patient�s own blood stem cells are removed, the patient is then treated with high doses of chemotherapy and/or radiation therapy to kill the cancer, after which the blood stem cells are returned to the patient. It is a common procedure for patients with multiple myeloma.

A total of 568 patients with multiple myeloma, who had received no more than 12 months of prior therapy and no prior transplant, were enrolled between December 2004 and July 2009. All patients received autologous transplantation following a high dose of a drug called melphalan, which is commonly used to treat multiple myeloma. Ultimately, 460 patients who had adequate organ function and no evidence of progressive disease, were randomized between 90 and 100 days after transplant to receive lenalidomide or placebo. Patients began lenalidomide or placebo between day 100 to 110 and continued until they had evidence of progressive disease.

Among the patients who received placebo, half had their myeloma progress (worsen) within an estimated 778 days. In contrast, for those patients taking lenalidomide, a median time to progression cannot be defined because fewer than half the patients had worsening of their myeloma. This represents a 58 percent reduction in the risk of disease progression for the group taking lenalidomide. This difference in time to progression was highly statistically significant.

This is the first randomized phase 3 trial (the final and most comprehensive aspect of a three-phase clinical trials process) to demonstrate a clinical benefit of lenalidomide following transplant for multiple myeloma. However, the trial has not yet shown evidence of an overall survival benefit.

The types of side effects observed in this trial were similar to those observed in other clinical trials with lenalidomide. Detailed results from this trial will be presented at a future scientific meeting.

"This study answers the important question for multiple myeloma patients regarding maintenance lenalidomide therapy starting at 100 days following transplant," said Philip L. McCarthy, Jr., M.D., associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study. "We now know that prolonged maintenance therapy with lenalidomide when compared to placebo will delay disease progression. This is an exciting advance in the field of multiple myeloma therapy and occurred due to the willingness of multiple myeloma patients to participate in this study and to the cooperation of the many physicians and study groups involved."

Lenalidomide, a derivative of thalidomide, was approved by the U.S. Food and Drug Administration in 2006 to be used in combination with dexamethasone, a steroid, for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease. Celgene Corporation, Summit, N.J., provided lenalidomide for this trial under a clinical trials agreement with NCI.

"This trial is a prime example of an important study question that was effectively carried out by collaboration between NCI-sponsored oncology cooperative groups, NCI, and NHLBI co-sponsored Blood and Marrow Clinical Trials Network with support from Celgene Corp., the discoverer, developer, and manufacturer of lenalidomide. This collaboration made it possible to rapidly complete accrual to the trial and to provide information in a timely manner that informs an important change in medical practice," said Richard F. Little, M.D., head, Blood and AIDS Cancers Therapeutics Section of NCI's Cancer Therapy Evaluation Program, part of the Division of Cancer Treatment and Diagnosis.

Multiple myeloma occurs when a type of immune cell, called a plasma cell, becomes too numerous and crowds out healthy blood cells in the bone marrow (the spongy tissue inside the bones), causing pain, and gradually damaging the bones and other body organs. An estimated 20,580 people will be diagnosed with multiple myeloma in the United States in 2009. Approximately 46,000 people are living with the disease in the United States.

CALGB 100104/ECOG 100104: A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 Or Placebo Following Autologous Stem Cell Transplantation For Multiple Myeloma. An overview of the design and entry criteria for this trial can be found at http://www.Cancer.Gov/Clinicaltrials/Calgb-100104 (Clinical Trial Registry number NCT00114101).

For more information about cancer, please visit the NCI Web site at http://www.cancer.gov, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics.

NCI leads the National Cancer Program and the NIH effort to dramatically reduce the burden of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers.

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Food

2010-01-27T07:40:00.000-08:00

Keeping Food Safe During an Emergency

Did you know that a flood, fire, national disaster, or the loss of power from high winds, snow, or ice could jeopardize the safety of your food? Knowing how to determine if food is safe and how to keep food safe will help minimize the potential loss of food and reduce the risk of foodborne illness. This fact sheet will help you make the right decisions for keeping your family safe during an emergency.

ABCD’s of Keeping Food Safe in an Emergency

Always keep meat, poultry, fish, and eggs refrigerated at or below 40 °F and frozen food at or below 0 °F. This may be difficult when the power is out.

Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature. The refrigerator will keep food safely cold for about 4 hours if it is unopened. A full freezer will hold the temperature for approximately 48 hours (24 hours if it is half full) if the door remains closed. Obtain dry or block ice to keep your refrigerator as cold as possible if the power is going to be out for a prolonged period of time. Fifty pounds of dry ice should hold an 18-cubic foot full freezer for 2 days. Plan ahead and know where dry ice and block ice can be purchased.

Be prepared for an emergency...

... by having items on hand that don’t require refrigeration and can be eaten cold or heated on the outdoor grill. Shelf-stable food, boxed or canned milk, water, and canned goods should be part of a planned emergency food supply. Make sure you have ready-to-use baby formula for infants and pet food. Remember to use these items and replace them from time to time. Be sure to keep a hand-held can opener for an emergency.

Consider what you can do ahead of time to store your food safely in an emergency. If you live in a location that could be affected by a flood, plan your food storage on shelves that will be safely out of the way of contaminated water. Coolers are a great help for keeping food cold if the power will be out for more than 4 hours—have a couple on hand along with frozen gel packs. When your freezer is not full, keep items close together—this helps the food stay cold longer.

Digital, dial, or instant-read food thermometers and appliance thermometers will help you know if the food is at safe temperatures. Keep appliance thermometers in the refrigerator and freezer at all times. When the power is out, an appliance thermometer will always indicate the temperature in the refrigerator and freezer no matter how long the power has been out. The refrigerator temperature should be 40 °F or below; the freezer, 0 °F or lower. If you’re not sure a particular food is cold enough, take its temperature with a food thermometer.

Frequently Asked Questions:

Q.	Flood waters covered our food stored on shelves and in cabinets. What can I keep and what should I throw out?
A.	Do not eat any food that may have come into contact with flood water. Discard any food that is not in a waterproof container if there is any chance that it has come into contact with flood water. Food containers that are not waterproof include those with screw-caps, snap lids, pull tops, and crimped caps. Also, discard cardboard juice/milk/baby formula boxes and home canned foods if they have come in contact with flood water, because they cannot be effectively cleaned and sanitized. Inspect canned foods and discard any food in damaged cans. Can damage is shown by swelling, leakage, punctures, holes, fractures, extensive deep rusting, or crushing/denting severe enough to prevent normal stacking or opening with a manual, wheel-type can opener. Steps to Salvage All-Metal Cans and Retort Pouches Undamaged, commercially prepared foods in all-metal cans and retort pouches (for example, flexible, shelf-stable juice or seafood pouches) can be saved if you do the following: Remove the labels, if they are the removable kind, since they can harbor dirt and bacteria. Thoroughly wash the cans or retort pouches with soap and water, using hot water if it is available. Brush or wipe away any dirt or silt. Rinse the cans or retort pouches with water that is safe for drinking, if available, since dirt or residual soap will reduce the effectiveness of chlorine sanitation. Then, sanitize them by immersion in one of the two following ways: Place in water and allow the water to come to a boil and continue boiling for 2 minutes, or Place in a freshly made solution consisting of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available) for 15 minutes. Air-dry cans or retort pouches for a minimum of 1 hour before opening or storing. If the labels were removable, then re-label your cans or retort pouches, including the expiration date (if available), with a marker. Food in reconditioned cans or retort pouches should be used as soon as possible, thereafter. Any concentrated baby formula in reconditioned, all-metal containers must be diluted with clean, drinking water.

Q.	How should I clean my pots, pans, dishes, and utensils?
A.	Thoroughly wash metal pans, ceramic dishes, and utensils (including can openers) with soap and water, using hot water if available. Rinse and then sanitize them by boiling in clean water or immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available).

Q.	How should I clean my countertops?
A.	Thoroughly wash countertops with soap and water, using hot water if available. Rinse and then sanitize them by applying a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available). Allow to air-dry.

Q.	My home was flooded and I am worried about the safety of the drinking water. What should I do?
A.	Use bottled water that has not been exposed to flood waters if it is available. If you don't have bottled water, you should boil water to make sure it is safe. Boiling water will kill most types of disease-causing organisms that may be present. If the water is cloudy, filter it through clean cloths or allow it to settle, and draw off the clear water for boiling. Boil the water for one minute, let it cool, and store it in clean containers with covers. If you can't boil water, you can disinfect it using household bleach. Bleach will kill some, but not all, types of disease-causing organisms that may be in the water. If the water is cloudy, filter it through clean cloths or allow it to settle, and draw off the clear water for disinfection. Add 1/8 teaspoon (or 8 drops) of regular, unscented, liquid household bleach for each gallon of water, stir it well and let it stand for 30 minutes before you use it. Store disinfected water in clean containers with covers. If you have a well that had been flooded, the water should be tested and disinfected after flood waters recede. If you suspect that your well may be contaminated, contact your local or state health department or agriculture extension agent for specific advice.

Q.	We had a fire in our home and I am worried about what food I can keep and what to throw away.
A.	Discard food that has been near a fire. Food exposed to fire can be damaged by the heat of the fire, smoke fumes, and chemicals used to fight the fire. Food in cans or jars may appear to be okay, but the heat from a fire can activate food spoilage bacteria. If the heat is extreme, the cans or jars themselves can split or rupture, rendering the food unsafe. One of the most dangerous elements of a fire is sometimes not the fire itself, but toxic fumes released from burning materials. Discard any raw food or food in permeable packaging—cardboard, plastic wrap, screw-topped jars, bottles, etc.—stored outside the refrigerator. Food stored in refrigerators or freezers can also become contaminated by fumes. The refrigerator seal isn't airtight and fumes can get inside. Chemicals used to fight the fire contain toxic materials and can contaminate food and cookware. Food that is exposed to chemicals should be thrown away—the chemicals cannot be washed off the food. This includes food stored at room temperature, such as fruits and vegetables, as well as food stored in permeable containers like cardboard and screw-topped jars and bottles. Cookware exposed to fire-fighting chemicals can be decontaminated by washing in soap and hot water. Then submerge for 15 minutes in a solution of 1 tablespoon unscented, liquid chlorine bleach per gallon of water.

Q.	A snowstorm knocked down the power lines, can I put the food from the refrigerator and freezer out in the snow?
A.	No, frozen food can thaw if it is exposed to the sun's rays even when the temperature is very cold. Refrigerated food may become too warm and foodborne bacteria could grow. The outside temperature could vary hour by hour and the temperature outside will not protect refrigerated and frozen food. Additionally, perishable items could be exposed to unsanitary conditions or to animals. Animals may harbor bacteria or disease; never consume food that has come in contact with an animal. Rather than putting the food outside, consider taking advantage of the cold temperatures by making ice. Fill buckets, empty milk cartons or cans with water and leave them outside to freeze. Then put the homemade ice in your refrigerator, freezer, or coolers.

Q.	Some of my food in the freezer started to thaw or had thawed when the power came back on. Is the food safe? How long will the food in the refrigerator be safe with the power off?
A.	Never taste food to determine its safety! You will have to evaluate each item separately. If an appliance thermometer was kept in the freezer, read the temperature when the power comes back on. If the appliance thermometer stored in the freezer reads 40 °F or below, the food is safe and may be refrozen. If a thermometer has not been kept in the freezer, check each package of food to determine the safety. Remember you can’t rely on appearance or odor. If the food still contains ice crystals or is 40 °F or below, it is safe to refreeze. Refrigerated food should be safe as long as power is out no more than 4 hours. Keep the door closed as much as possible. Discard any perishable food (such as meat, poultry, fish, eggs, and leftovers) that have been above 40 °F for 2 hours.

Q.	May I refreeze the food in the freezer if it thawed or partially thawed?
A.	Yes, the food may be safely refrozen if the food still contains ice crystals or is at 40 °F or below. You will have to evaluate each item separately. Be sure to discard any items in either the freezer or the refrigerator that have come into contact with raw meat juices. Partial thawing and refreezing may reduce the quality of some food, but the food will remain safe to eat. See the attached charts for specific recommendations.

Refrigerator Foods

When to Save and When to Throw It Out
FOOD	Held above 40 °F for over 2 hours
MEAT, POULTRY, SEAFOOD Raw or leftover cooked meat, poultry, fish, or seafood; soy meat substitutes	Discard
Thawing meat or poultry	Discard
Meat, tuna, shrimp,chicken, or egg salad	Discard
Gravy, stuffing, broth	Discard
Lunchmeats, hot dogs, bacon, sausage, dried beef	Discard
Pizza – with any topping	Discard
Canned hams labeled "Keep Refrigerated"	Discard
Canned meats and fish, opened	Discard
CHEESE Soft Cheeses: blue/bleu, Roquefort, Brie, Camembert, cottage, cream, Edam, Monterey Jack, ricotta, mozzarella, Muenster, Neufchatel, queso blanco, queso fresco	Discard
Hard Cheeses: Cheddar, Colby, Swiss, Parmesan, provolone, Romano	Safe
Processed Cheeses	Safe
Shredded Cheeses	Discard
Low-fat Cheeses	Discard
Grated Parmesan, Romano, or combination (in can or jar)	Safe
DAIRY Milk, cream, sour cream, buttermilk, evaporated milk, yogurt, eggnog, soy milk	Discard
Butter, margarine	Safe
Baby formula, opened	Discard
EGGS Fresh eggs, hard-cooked in shell, egg dishes, egg products	Discard
Custards and puddings	Discard
CASSEROLES, SOUPS, STEWS	Discard
FRUITS Fresh fruits, cut	Discard
Fruit juices, opened	Safe
Canned fruits, opened	Safe
Fresh fruits, coconut, raisins, dried fruits, candied fruits, dates	Safe
SAUCES, SPREADS, JAMS Opened mayonnaise, tartar sauce, horseradish	Discard if above 50 °F for over 8 hrs.
Peanut butter	Safe
Jelly, relish, taco sauce, mustard, catsup, olives, pickles	Safe
Worcestershire, soy, barbecue, Hoisin sauces	Safe
Fish sauces (oyster sauce)	Discard
Opened vinegar-based dressings	Safe
Opened creamy-based dressings	Discard
Spaghetti sauce, opened jar	Discard
BREAD, CAKES, COOKIES,PASTA, GRAINS Bread, rolls, cakes, muffins, quick breads, tortillas	Safe
Refrigerator biscuits,rolls, cookie dough	Discard
Cooked pasta, rice, potatoes	Discard
Pasta salads with mayonnaise or vinaigrette	Discard
Fresh pasta	Discard
Cheesecake	Discard
Breakfast foods –waffles, pancakes, bagels	Safe
PIES, PASTRY Pastries, cream filled	Discard
Pies – custard,cheese filled, or chiffon; quiche	Discard
Pies, fruit	Safe
VEGETABLES Fresh mushrooms, herbs, spices	Safe
Greens, pre-cut, pre-washed, packaged	Discard
Vegetables, raw	Safe
Vegetables, cooked; tofu	Discard
Vegetable juice, opened	Discard
Baked potatoes	Discard
Commercial garlic in oil	Discard
Potato Salad	Discard

Frozen Food

When to Save and When To Throw It Out
FOOD	Still contains ice crystals and feels as cold as if refrigerated	Thawed. Held above 40 °F for over 2 hours
MEAT, POULTRY, SEAFOOD Beef, veal, lamb, pork, and ground meats	Refreeze	Discard
Poultry and ground poultry	Refreeze	Discard
Variety meats (liver, kidney, heart, chitterlings)	Refreeze	Discard
Casseroles, stews, soups	Refreeze	Discard
Fish, shellfish, breaded seafood products	Refreeze. However, there will be some texture and flavor loss.	Discard
DAIRY Milk	Refreeze. May lose some texture.	Discard
Eggs (out of shell) and egg products	Refreeze	Discard
Ice cream, frozen yogurt	Discard	Discard
Cheese (soft and semi-soft)	Refreeze. May lose some texture.	Discard
Hard cheeses	Refreeze	Refreeze
Shredded cheeses	Refreeze	Discard
Casseroles containing milk, cream, eggs, soft cheeses	Refreeze	Discard
Cheesecake	Refreeze	Discard
FRUITS Juices	Refreeze	Refreeze. Discard if mold, yeasty smell, or sliminess develops.
Home or commercially packaged	Refreeze. Will change texture and flavor.	Refreeze. Discard if mold, yeasty smell, or sliminess develops.
VEGETABLES Juices	Refreeze	Discard after held above 40 °F for 6 hours.
Home or commercially packaged or blanched	Refreeze. May suffer texture and flavor loss.	Discard after held above 40 °F for 6 hours.
BREADS, PASTRIES Breads, rolls, muffins, cakes (without custard fillings)	Refreeze	Refreeze
Cakes, pies, pastries with custard or cheese filling	Refreeze	Discard
Pie crusts, commercial and homemade bread dough	Refreeze. Some quality loss may occur.	Refreeze. Quality loss is considerable.
OTHER Casseroles – pasta, rice based	Refreeze	Discard
Flour, cornmeal, nuts	Refreeze	Refreeze
Breakfast items –waffles, pancakes, bagels	Refreeze	Refreeze
Frozen meal, entree, specialty items (pizza, sausage and biscuit, meat pie,convenience foods)	Refreeze	Discard

http://medicalinformation-dobi.blogspot.com/search/label/Food

Drugs

2010-01-27T07:37:00.000-08:00

Drugs to be Discontinued

Companies are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition. From time to time, FDA also receives notification for other products. These discontinuations are provided below for informational purposes only.

To locate drugs that have already been discontinued, please consult the following:
Drugs@FDA
Orange Book Query
Orange Book Monthly Additions and Deletions

Drug Name	Company Information	Related Information
Agenerase (amprenavir) 150mg capsule updated 10/10/2007	GlaxoSmithKline 888...	Letter from GlaxoSmithKline (updated 10/10/2007)
5% Alcohol in 5% Dextrose Injection, USP, Glass Container 12/19/2007	Hospira, Inc. 877-946-7747	Hospira has made a business decision to discontinue manufacturing of 5% Alcohol in 5% Dextrose Injection drug product (NDC# 0409-1500-05)
Brevibloc Concentrate (esmolol HCl) 250 mg/mL, 10 mL ampul 8/24/2007	Baxter Healthcare Corporation	Baxter Healthcare Corporation has made a decision to discontinue Brevibloc Concentrate (esmolol HCl) 250 mg/mL, 10 mL ampul (NDC 10019-025-18 for the pack and NDC 10019-025-73 for the ampul). Letter from Baxter
Calciferol injection in oil (ergocalciferol) 3/19/2004	Schwarz Pharma 6140 W. Executive Drive Mequon, WI 53092 800-558-5114	Schwarz has discontinued manufacturing of calciferol
CEFOTAN (cefotetan injection) 6/9/2006	AstraZeneca Pharmaceuticals LP (AstraZeneca) - Contact Corporate Information Center at 800-236-9933.	The remaining inventory of CEFOTAN (cefotetan injection) has been depleted. AstraZeneca has no further plans to manufacture or distribute CEFOTAN (cefotetan injection). Other cefotetan injection products continue to be available.
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) 6/5/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
Cortisporin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) 6/5/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
Cylert (pemoline) tablets and chewable tablets, all strengths 5/25/2005	Abbott Laboratories	Abbott has made the decision to discontinue Cylert tablets and chewable tablets Letter from Abbott
Cytoxan (cyclophosphamide) 25mg and 50mg tablets 9/24/2007	Bristol-Myers Squibb Company 609-897-2412	Bristol-Myers Squibb Company has made a decision to discontinue Cytoxan (cyclophosphamide) 25mg and 50mg tablets. Alternate products continue to be available from other companies.
Desyrel (trazodone) Tablets 50mg, 100mg, 150mg and 300mg tablets 9/21/2006	Bristol-Myers Squibb Company 609-897-2412	Alternate products continue to be available from other companies. Dear Healthcare Professional Letter
ELAVIL (amitriptyline hydrochloride) Tablets and Injection. 5/15/2003	AstraZeneca Pharmaceuticals LP (AstraZeneca) – Contact Corporate Information Center at: 800-236-9933	ELAVIL Injection is no longer available at AstraZeneca. The remaining inventory of ELAVIL Tablets will be depleted by December 31, 2003. AstraZeneca has no further plans to manufacture ELAVIL (amitriptyline hydrochloride) Tablets or Injection.
Emergency Syringes 12/08/2009	Amphastar/IMS	List of Products to Be Discontinued by Amphastar/IMS (PDF - 15KB) These emergency syringes remain available in similar presentations from Hospira. Hospira Customer Care may be contacted at 1-877-9... regarding alternate products that remain available.
Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets 9/17/2007	Shire US Inc. 725 Chesterbrook Blvd. Wayne, Pa 19087 1-800-828-2088	Dear Healthcare Professional Letter
Exubera (insulin recombinant human, powder for inhalation) 10/19/2007	Pfizer 800-398-2372	Dear Healthcare Provider Letter
Faslodex* (fulvestrant) Injection, 2.5 ml (2 x 2.5 ml pre-filled syringe), (125 mg /2.5 ml (50 mg/ml) FASLODEX intramuscular injection), NDC 0310-0720-2510 11/2/2009	AstraZeneca Pharmaceuticals LP (AstraZeneca)-Contact the Corporate Communication Center at 1-800-236-9933	There is no remaining inventory within AstraZeneca's distribution network. The final expiration date of any Faslodex* (fulvestrant) Injection that may still be remaining in the market place is December 31, 2010. (The supply of the single 5.0 ml syringe [250 mg/5 ml (50 mg/ml)] Faslodex pack, NDC 0310-0720-50, is not affected, and is currently available.)
Florinef (fludrocortisone acetate tablets, USP) 6/8/2007	King Pharmaceuticals, Inc. 501 Fifth Street Bristol, Tennessee 37620 Professional Information Services Department: 800...	Dear Healthcare Provider Letter
Flovent Rotadisk (fluticasone propionate inhalation powder) 8/31/2004	GlaxoSmithKline 888-825-5249	Please see Dear Healthcare Professional letter for additional information.
Fortovase (saquinavir) capsules 200 mg 6/2/2005	Roche	Fortovase 200 mg capsules will be discontinued by February 15, 2006. Please see attached DHP letter for additional information. Dear Healthcare Professional Letter
Foscavir (foscarnet sodium) injection 10/31/2008	AstraZeneca Pharmaceuticals LP (AstraZeneca) Contact Corporate Information Center at 1-800-236-9933	The remaining inventory of Foscavir (foscarnet sodium) injection will be depleted by April 30, 2009. AstraZeneca has no further plans to manufacture or distribute Foscavir (foscarnet sodium) injection after April 30, 2009.
Geocillin (carbenicillin indanyl sodium) tablets 382 mg 4/8/2008	Pfizer	Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets.
Geref Diagnostic (sermorelin acetate for injection) 0.05mg base/amp 8/5/2008	EMD Serono 1-888-398-4567	EMD Serono has made a business decision to discontinue this product. Dear Healthcare Professional Letter
Humatin (Paromomycin Sulfate Capsules, USP) 2/7/2008	King Pharmaceuticals Professional Information Services Department 800-776-3637	King Pharmaceuticals has made a decision to discontinue Humatin (Paromomycin Sulfate Capsules, USP) Paromomycin continues to be available from another manufacture. Letter from King Pharmaceuticals
Humulin 50/50 Insulin updated 12/2/2009	Eli Lilly and Company 1-800-545-5979	Dear Healthcare Professional Letter (PDF - 201KB) Patient Information (PDF - 887KB)
Humulin U ULTRALENTE (HUMAN INSULIN [rDNA ORIGIN] EXTENDED ZINC SUSPENSION) 7/6/2005	Eli Lilly and Company	Dear Doctor Letter Patient Information
Humulin L LENTE (HUMAN INSULIN [rDNA ORIGIN] ZINC SUSPENSION) 7/6/2005	Eli Lilly and Company	Dear Doctor Letter Patient Information
HIVID (zalcitabine) tablets 7/26/2006	Roche Pharmaceuticals	The sale and distribution of its anti-HIV medication HIVID (zalcitabine) Tablets will be discontinued by December 31, 2006. Dear Health Care Professional Letter
Intal Inhaler (cromolyn sodium inhalation aerosol) 8/3/2009	King Pharmaceuticals	Dear Healthcare Professional Letter
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) 6/2/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
Inversine (mecamylamine hydrochloride) Tablets, 2.5 mg 6/17/2009	Targacept, Inc. 336-480-2100	Dear Healthcare Professional Letter
Inulin in Sodium Chloride Injection, USP 9/26/2003	Questcor Pharmaceuticals, Inc.	Letter
Kefzol (cefazolin) all presentations 2/28/2003	Eli Lilly and Company	Letter
Kefurox (cefuroxime) all presentations 2/28/2003	Eli Lilly and Company	Letter
Kemadrin (procyclidine hydrochloride) 6/6/2008	King Pharmaceuticals 800-776-3637	Letter from King Pharmaceuticals
Lanoxin Elixir(digoxin) 6/3/2005	GlaxoSmithKline	This product has been discontinued by GSK. Roxane is producing digoxin elixir.
LEXXEL (enalapril maleate-felodipine ER) Tablets 12/19/2007	AstraZeneca LP (AstraZeneca) - Contact Corporate Information Center at 800-236-9933.	LEXXEL Tablets will be discontinued on July 31, 2008. AstraZeneca has no further plans to manufacture or distribute LEXXEL (enalapril maleate-felodipine ER) Tablets after July 31, 2008.
Lorabid (loracarbef, USP) capsules and suspension 10/27/2006	King Pharmaceuticals 888-840-5370	Letter from King Pharmaceuticals
Mandol (cefamandole) all presentations 2/28/2003	Eli Lilly and Company	Letter
Mitozytrex (Mitomycin for Injection) 9/12/2008	SuperGen (925) 560-0100	Other Mitomycin approved products continue to be available. This product was never commercialized.
Mivacron (mivacurium chloride) injection 6/23/2006	Abbott Laboratories	Alternative products that can be used in place of Mivacron continue to be available. Please call Abbott at 1-8... for additional information.
Moban (molindone hydrochloride) 5 mg, 10 mg, 25 mg, and 50 mg Tablets 1/13/2010	Endo Pharmaceuticals Inc. 1-800-462-ENDO (1-800-462-3636)	Moban tablets have been discontinued and supplies are anticipated to be depleted by June 30, 2010.
Nandrolone Decanoate Injection 6/24/2009	Watson Pharmaceuticals (800) 272-5525	Watson Pharmaceuticals has discontinued this product because of the unavailability of the active pharmaceutical ingredient.
Neutrexin (trimetrexate glucuronate) Injection 6/14/2007	MedImmune, Inc.	Dear Healthcare Professional Letter
Nimotop (nimodipine) capsules 10/31/2008	Bayer HealthCare Pharmaceuticals 888-842-2937	Generic nimodipine remains available. Please see Dear Healthcare Professional Letter for additional information.
Nolvadex (tamoxifen citrate) 4/10/2006	AstraZeneca 800-236-9933	Letter
Novolin InnoLet disposable pens and Novolin PenFill 3 mL cartridges for Novolin R, N and 70/30 8/13/2009	Novo Nordisk 1-800-727-6500	Dear Healthcare Provider Letter Dear Patient Letter
Novolin L, Lente, human insulin zinc suspension [rDNA origin] 7/15/2003	Novo Nordisk Pharmaceuticals, Inc. Contact: 800... Customer Service	Letter
NPH Iletin II (ISOPHANE INSULIN SUSPENSION, USP, PURIFIED PORK) 7/6/2005	Eli Lilly and Company	Dear Doctor Letter Patient Information Frequently Asked Questions
ORLAAM (Levomethadyl hydrochloride acetate) Oral Solution, 10 mg/mL 9/2/2003	Roxane Laboratories	Letter
Pancrease (pancrelipase) capsules 5/17/2006	McNeil Consumer and Specialty Pharmaceuticals 888-440-7903	Other pancrelipase products continue to be available Dear Health Care Provider Letter
Perchloracap (potassium perchlorate) 200 mg capsules 6/2/2005	Tyco Healthcare	Perchloracap capsules have been discontinued and supplies are anticipated to be depleted by the end of 2005.
Procanbid (Procanamide Hydrochloride Extended-Release Tablets) 11/9/2007	King Pharmaceuticals 800-776-3637	Dear Prescriber Letter
ProSom (estazolam) Updated 5/2/2007	Abbott 200 Abbott Park Road Abbott Park, IL 60064-6157 Customer Service: 800...	Dear Health Care Provider Letter
Pulmicort Turbuhaler 200mcg (budesonide inhalation powder) 5/16/2007	AztraZeneca 1800 Concord Pike PO Box 8355 Wilmington DE 19803-8355 Corporate Information: 800-842-9920	NDA 20-441, PULMICORT TURBUHALER 200 mcg (budesonide inhalation powder) will no longer be available at AstraZeneca. The introduction of PULMICORT FLEXHALER (budesonide inhalation powder, 90 & 180 mcg), NDA 21-949, will be accompanied by the phasing out of PULMICORT TURBUHALER so as to minimize confusion in the marketplace. AstraZeneca has no further plans to manufacture NDA 20-441, PULMICORT TURBUHALER 200 mcg (budesonide inhalation powder).
Regular Iletin II (INSULIN INJECTION, USP, PURIFIED PORK) 7/6/2005	Eli Lilly and Company	Dear Doctor Letter Patient Information Frequently Asked Questions
Revex (Nalmefene HCl Injection) 1mg/mL, 2 mL ampule and 0.1mg/mL, 1mL ampule 7/9/2008	Baxter Healthcare Corporation 888-229-0001	Baxter has discontinued Revex production.
Roferon-A (Interferon alfa-2a, Recombinant) 11/29/2007	Hoffmann -La Roche Inc. 800-526-6367	Dear Healthcare Professional Letter
SecreFlo (porcine secretin for injection, 16 mcg/vial) 10/1/2008	ChiRhoClin, Inc., 1-877-272-4888	Please see Dear Healthcare Professional Letter for additional information.
Serevent Inhalation Aerosol 6/10/2003	GlaxoSmithKline 800-340-3236	GSK anticipates that SEREVENT Inhalation Aerosol will no longer be available starting in June 2003. Dear Health Care Professional Letter from GlaxoSmithKline
Sporanox (itraconazole) Injection 10/11/2007	Ortho Biotech	Please see Dear Health Care Professional letter for additional information.
Stelazine (trifluoperazine) oral concentrate 10mg/ml Stelazine (trifluoperazine) tablets (1mg, 2mg, 5mg, 10mg) Stelazine (trifluoperazine) Injection 2mg/ml 12/18/2003	GlaxoSmithKline 888-825-5249	Stelazine was discontinued and withdrawn from the market. The final lots were distributed by GSK August 2003 and the final expiry date of all products in the marketplace is no later than January 31, 2004.
Suprax (cefixime) updated 2/25/2004	Lederle/Wyeth Pharmaceuticals	Discontinued July 2002. Stock will be distributed until exhausted or until March 2003, whichever comes first. For additional information, please call customer service (800) 6... Lupin Pharmaceuticals recently received approval for cefixime 400 mg tablets and cefixime 100 mg/5 ml suspension. For further information, please contact Lupin Pharmaceuticals at 410... (2/25/2004)
Tenormin (atenolol) 0.5mg/ml Injection 2/28/2008	AstraZeneca Pharmaceuticals LP (AstraZeneca) – Contact Corporate Information Center: 800...	AstraZeneca has made a business decision to discontinue Tenormin (atenolol) 0.5 mg/ml injection.
Teslac (testolactone tablets, USP) 50mg tablets 2/26/2008	Bristol-Myers Squibb 609-897-2412	Bristol-Myers Squibb Company has made a decision to discontinue Teslac (testolactone tablets, USP) 50mg tablets. Letter from Bristol-Myers Squibb
Tequin (gatifloxacin) Tablets and Injection 5/12/2006	Bristol-Meyers Squibb	See attached letter
Tilade Inhaler (nedocromil sodium inhalation aerosol) 5/2/2008	King Pharmaceuticals 800-776-3637	Dear Healthcare Professional Letter (4/30/2008)
Valstar (valrubicin) Solution for Intravesical Instillation 1/30/2004	Formerly distributed by Celltech Celltech Customer Service 888-963-3382	No further availability planned at this time.
Velosulin BR Human, Buffered Regular Human Insulin Injection [rDNA origin] 11/3/2003	Novo Nordisk Pharmaceuticals, Inc. Contact: 800-727-6500 Customer Service	Dear Healthcare Professional Letter
Vesanoid (tretinoin) Soft Gelatin Capsule 10 mg 12/17/2009	Hoffmann-La Roche Inc	Please see the Dear Customer Letter titled: Vesanoid 10mg (tretinoin) Product Deletion at: Vesanoid Teva is increasing supply of their tretinoin 10mg capsules to meet market demand (NDC 00555-0808-02).
Videx (didanosine) chewable/dispersable buffered tablets 9/19/2006	BMS	Dear Healthcare Professional Letter
1.5% Xylocaine -MPF with Dextrose 7.5% Injection (lidocaine HCl and dextrose anhydrous Injection ampules) 8/29/2005	AstraZeneca 800-842-9920	1.5% Xylocaine® -MPF with Dextrose 7.5% Injection is no longer available at AstraZeneca. The remaining inventory of 1.5% Xylocaine® -MPF with Dextrose 7.5% Injection Ampules will be depleted by August 31, 2005. AstraZeneca has no further plans to manufacture 1.5% Xylocaine® -MPF with Dextrose 7.5% Injection Ampules
Zenapax (daclizumab) sterile Concentrate for Injection 12/18/2009	Hoffman-La Roche	Please see Dear Healthcare Professional Letter for additional information
Zovirax (acyclovir sodium) for injection 1000mg/20ml vial 1/6/2004	GlaxoSmithKline Customer Service 800-877-1158	Letter from GSK
Zyflo (zileuton) tablets 2/20/2008	Critical Therapeutics, Inc.	Zyflo CR continues to be available. Dear Healthcare Professional Letter

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Alert

2010-01-25T08:43:00.000-08:00

Willamette Shelling Recalls Shelled

Hazelnuts Because of Possible Health Risk

Contact:
Ben Mitchell
503-538-9256
Amy Wood
503-274-0086, ext. 2

FOR IMMEDIATE RELEASE - December 17, 2009 - Willamette Filbert Growers of Newberg, OR is recalling 29,861 lbs of Shelled Hazelnuts and Shelled Organic Hazelnuts, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

After product sampling, Salmonella was found on one production lot at the facility where Willamette Filbert Grower's hazelnuts were shelled. To ensure consumer safety, Willamette Filbert Growers has decided to recall all shelled hazelnuts and shelled organic hazelnuts processed from October 12th 2009 through November 25th 2009.

Shelled Hazelnuts and Shelled Organic Hazelnuts were distributed in Oregon and California through wholesale distributors and direct delivery. Unshelled hazelnuts are not subject to this recall.

All products subject to recall were packed in 25 lbs. corrugated boxes bearing Willamette Filbert Growers or Meridian Organic Hazelnuts labeled with lot code numbers 289091A and 311091A.

No illnesses have been reported to date.

Consumers who have purchased Willamette Filbert Growers Shelled Hazelnuts or Meridian Organic Hazelnuts are urged to return the product to the place of purchase for a full refund. Consumers with questions may contact Ben Mitchell at (503) 538-9256, Monday through Friday, between 8 a.m. – 5 p.m. PST.

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Research

2010-01-25T08:39:00.000-08:00

Gene Linked to a Rare Form of Progressive Hearing Loss in Males is Identified

A gene associated with a rare form of progressive deafness in males has been identified by an international team of researchers funded by the National Institute on Deafness and Other Communication Disorders. The gene, PRPS1, appears to be crucial in inner ear development and maintenance. The findings are published in the December 17 early online issue of the American Journal of Human Genetics.

"This discovery offers exciting therapeutic implications," said James F. Battey, Jr., M.D., Ph.D., director of the NIDCD. "Not only does it give scientists a way to develop a targeted treatment for hearing loss in boys with this disorder, it may also open doors to the treatment of other types of deafness, including some forms of acquired hearing loss."

The gene is associated with DFN2, a progressive form of deafness that primarily affects males. Boys with DFN2 begin to lose their hearing in both ears roughly between the ages of 5 and 15, and over the course of several decades will experience hearing loss that can range from severe to profound. Their mothers, who carry the defective PRPS1 gene, may experience hearing loss as well, but much later in life and in a milder form. Families with DFN2 have been identified in the United States, Great Britain, and China.

The NIDCD-funded researchers led by Xue Zhong Liu, M.D., Ph.D., of the University of Miami Miller School of Medicine, discovered that the PRPS1 gene encodes the enzyme phosphoribosylpyrophosphate (PRPP) synthetase 1, which produces and regulates PRPP (phospho-ribosylpyrophosphate), and appears to play a key role in inner ear development and maintenance. The four mutations identified in the PRPS1 gene cause a decrease in the production of the PRPP synthetase 1 protein that results in defects in sensory cells (called hair cells) in the inner ear, and eventually leads to progressive deafness.

"PRPS1 is an interesting example of a human disease gene in which gain of function or loss of function mutations cause several different and distinct hereditary disorders," says Dr. Liu. "Our findings emphasize the body's need for tight regulation of PRPP synthetase 1 since a drop in activity can lead to deafness." Other mutations in the PRPS1 gene have been linked to neurodegenerative disorders such as Arts syndrome and a form of Charcot-Marie Tooth disease, both of which feature deafness in the constellation of symptoms.

Knowing that a reduction in the amount of PRPP synthetase 1 is what causes deafness in DFN2, Liu and his colleagues are now exploring potential enzyme replacement therapies to either restore hearing or prevent further hearing loss in boys with DFN2. Since the PRPS1 mutations can be used as a genetic marker for DFN2, in the future at-risk boys could be tested at birth and immediately put on enzyme replacement therapy to reduce or prevent the hearing loss that would ordinarily come later in life.

In addition, the knowledge that scientists gather about the mechanisms of PRPS1 potentially could be used to develop treatments to combat acquired hearing loss, such as the hearing loss caused by drugs that are used in some chemotherapy regimens and treatments for HIV/AIDS. These are powerful and helpful medications, but they have the unfortunate side effect of damaging, even killing, hair cells in the inner ear. The results from this study open the possibility for improving these life-saving treatments by eliminating or reducing the disabling side effect of hearing loss.

In addition to NIDCD support, the following institutions collaborated in this study: Chinese PLA General Hospital, Beijing; University of Science and Technology of China, Hefei; Chinese Academy of Sciences, Hefei; Guizhou Provincial People�s Hospital, GuiYang, China; UCL Institute of Child Health, London; Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, and Shanghai Second Medical University, Shanghai; Department of Genetics, Harvard Medical School, Boston; Massachusetts Eye and Ear Infirmary, Boston; and Howard Hughes Medical Institute, Boston.

NIDCD supports and conducts research and research training on the normal and disordered processes of hearing, balance, smell, taste, voice, speech and language and provides health information, based upon scientific discovery, to the public. For more information about NIDCD programs, see the Web site at www.nidcd.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Alert

2010-01-25T08:35:00.000-08:00

Faribault Foods Voluntarily Recalls Three Lots of Health Valley Organic No Salt Added Split Pea Soup Due to the Presence of an Undeclared Allergen

FOR IMMEDIATE RELEASE - Faribault, MN - December 16, 2009 - Faribault Foods announced that it is recalling Health Valley Organic No Salt Added Split Pea Soup (15 oz.) with the lot codes 22JUL2011, 18AUG2011, and 11SEP2011 because of the presence of an undeclared dairy allergen. This soup contains butter and potatoes, which are not listed on the ingredient statements of the affected lots. No other lot codes of this product or any other Health Valley product is affected in any way.

Consumers who have an allergy or severe sensitivity to milk protein or potatoes run the potential risk of a health problem or illness if they consume these lots of product.

No confirmed illnesses have been reported to date.

The recalled product was distributed to food stores nationwide. The affected product and lot codes are as follows:

Health Valley Organic No Salt Added Split Pea Soup UPC CODE# 35742-22104
Lot codes: 22JUL2011 18AUG2011 11SEP2011

The lot code can be found on the bottom of each individual soup can.

Consumers who have purchased any products covered by this recall are urged to return them to the store of purchase for a full refund. Consumers with questions or concerns about the recall please call 1-800-4... (9:00 AM – 7:00 PM Eastern Time).

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Science

2010-01-25T08:33:00.000-08:00

Ambidextrous Children at Higher

Risk for Learning Problems

More likely than right-handed kids to have language problems, ADHD, study finds.

By Jennifer Thomas
HealthDay Reporter

MONDAY, Jan. 25 (HealthDay News) -- Ambidextrous children are more likely to have attention-deficit/hyperactivity disorder (ADHD), problems with language and schoolwork, and other mental health issues than right-handed children, new research suggests.

Children are considered ambidextrous if neither hand is dominant, where they switch between using the right and left hands for activities such as eating or writing, or they use their right hand for certain activities and the left for others.

In the study, researchers analyzed data on nearly 8,000 children born in 1985-1986 who participated in the Northern Finland Birth Cohort. Language difficulties, scholastic performance and mental health issues were assessed between ages 7 and 8 and again at age 16 through reports of symptoms from teachers, parents and the children themselves.

At age 8, children who were "mixed-handed" were twice as likely as right-handed children to have difficulties with schoolwork or language, such as with reading or their ability speak as well as their peers.

At age 16, mixed-handed children were twice as likely to have problems with language at school and scores on assessment tests indicating they likely had ADHD. Symptoms of ADHD include excessive fidgeting, inability to focus on a task or concentrate, impulsivity and poor school performance.

Mixed-hand children were also more likely to have signs of psychiatric disturbances, the researchers found.

The study authors noted that mixed-handedness could be useful in diagnosing children with ADHD and other mental health issues.

"Mixed-handedness together with the presence of behavioral problems can be a red flag," said study author Alina Rodriguez, of the department of psychology at Uppsala University in Sweden. "However, mixed-handedness alone does not necessarily imply that the child has problems. Mixed-handedness is one of a host of other known risk factors."

The study is published in the Jan. 25 online issue of Pediatrics.

About 1 percent of children in the study were identified by their parents as being mixed-handed, while about 8 percent of kids were left-handed. The researchers found no association with being left-handed and any of the scholastic or mental health impairments.

One explanation for why mixed-handed children may be more prone to language difficulties and ADHD is because being ambidextrous is a proxy for atypical cerebral lateralization, or differences in the structure and function of the brain.

The brain is normally specialized, Rodriguez explained, with the left hemisphere of the brain dominant in right-handed people. Mixed-handed people, however, have differences in the typical dominance pattern of the brain.

Prior research has suggested that children with dyslexia and with ADHD have disturbances in the right hemisphere.

Though the study is interesting, it's probably of limited use as a diagnostic tool, said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Schneider Children's Hospital in New Hyde Park, N.Y.

Most of the mixed-handed children in the study did not have ADHD, scholastic difficulties or any other mental health issues, he noted. And the majority of children who had ADHD or problems at school were not mixed-handed.

Still, it's an area that merits further research, Adesman said.

"Handedness has a relationship to brain development, and brain development has a relationship to ADHD and dyslexia," Adesman said. "The data support the idea that there seems to be an increased association between mixed-handedness and learning-attentional problems."

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Science

2010-01-25T08:31:00.000-08:00

Male Abusers Often Sabotage Birth Control With Partners

Study found physical violence often accompanied by attempts to get young women pregnant.

MONDAY, Jan. 25 (HealthDay News) -- A new report says that male partners of teenage girls and young women who engage in physical and sexual violence also often try to sabotage the birth control the women are using.

The study, which appears online in the January issue of Contraception, also finds that women who experience both birth-control sabotage and violence from their partner are twice as likely to have an unintended pregnancy.

"This study highlights an under-recognized phenomenon where male partners actively attempt to promote pregnancy against the will of their female partners," study author Elizabeth Miller, an assistant professor of pediatrics in the University of California at Davis School of Medicine, said in a news release from the school. "Not only is reproductive coercion associated with violence from male partners, but when women report experiencing both reproductive coercion and partner violence, the risk for unintended pregnancy increases significantly."

The study was conducted from 2008-2009 at five health clinics that deal with reproductive issues in Northern California. About 1,300 women aged 16 to 29 took part by responding to a computerized survey.

About 15 percent said they'd experienced birth-control sabotage, and more than half reported physical or sexual violence from a partner. More than one-third of those who said they had been the victim of partner violence also acknowledged experiencing either pregnancy coercion or birth-control sabotage, the researchers found.

"We have known about the association between partner violence and unintended pregnancy for many years," study senior author Jay Silverman, an associate professor of society, human development and health in the Harvard School of Public Health, said in the news release. "What this study shows is that reproductive coercion likely explains why unintended pregnancies are far more common among abused women and teens."

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Alert

2010-01-23T07:02:00.000-08:00

The Medicines Company Issues a Nationwide Recall for Certain Lots of Cleviprex® That May Contain Particulate Matter

FOR U.S. AUDIENCES ONLY

Company Contact:
1-888-977-6326
cleviprexrecall@themedco.com

FOR IMMEDIATE RELEASE - December 16, 2009 - Parsippany, N.J. - The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials during a routine annual inspection. The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.

The Medicines Company has not received any product complaints or reports of adverse events related to this issue. The Company is cooperating with the U.S. Food and Drug Administration on this recall.

The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns. When present in low numbers as observed, particles of this size are not known to constitute a health hazard. Experimental animal and human data indicate that they are scavenged by macrophages and other cells of the reticuloendothelial system without adverse effects. Although aggregates have not been observed, if the sub-visible particles were to aggregate, or if larger particles were present, then they could become visible and could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor. Unaffected product from lots 68-407-DJ, 68-408-DJ, 71-101-DJ and 71-106-DJ is being shipped to wholesalers and can be ordered by hospitals.

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com.

Any adverse reactions associated with the use of Cleviprex may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Health and

2010-01-23T06:59:00.000-08:00

HHS HealthBeat

(December 17, 2009)

Non-fighting words

Listen to Tip

Interested?
Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

Arguing can raise levels of body chemicals called cytokines, which fight infection. But continued high levels of cytokines are associated with conditions such as heart disease.

Researcher Jennifer Graham at Penn State has been looking at ways for couples to work on their differences without amping up their cytokines.

As part of her study, she had couples flip the hot switches on topics like money and in-laws.

Graham found that use of reasoning words during a fight controlled cytokines. So reasoning may be better than fighting, for your health and relationship – and:

[Jennifer Graham speaks] "Expressing yourself clearly and thinking deeply about conflict may also help lead to a resolution of the situation."

The study in the journal Health Psychology was supported by the National Institutes of Health.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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medical and science information

Health and

HHS HealthBeat

(December 31, 2009)

Practicing prevention

Alert

Janzen Farms Recalls Hazelnut Kernels Because of Possible Health Risks

Alert

FDA Warns Public of Continued Extortion Scam by FDA Impersonators

Treatment

HHS HealthBeat

(December 30, 2009)

Back to yoga

Alert

Treatment

Health and

Neighborhood Food Options Linked to Obesity in New York City

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Vitamin C May Reduce Risk of Gout

Drugs

Genetic Tests Help Optimize Doses of Blood-Thinning Drug

Alert

Mountain Man Nut & Fruit Co.® Announces Voluntary Recall of Hazelnut

Treatment

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and OlderAccelerated approval process used in vaccine approval

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(December 24, 2009)

When do you need more help?

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(December 22, 2009)

Yoga backs

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Kids without rotavirus

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Too Little Vitamin D May Worsen Asthma

Cancer

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Your Body Moves Through

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Drugs

Approved Drug Products with

Therapeutic Equivalence

Evaluations (Orange Book)

Alert

Teva Animal Health, Inc. expands a voluntary nationwide recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

Science

Health and

Drugs

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Drugs

Drugs to be Discontinued

Alert

Willamette Shelling Recalls Shelled

Hazelnuts Because of Possible Health Risk

Research

Alert

Faribault Foods Voluntarily Recalls Three Lots of Health Valley Organic No Salt Added Split Pea Soup Due to the Presence of an Undeclared Allergen

Science

Ambidextrous Children at Higher

Risk for Learning Problems

Science

Alert

The Medicines Company Issues a Nationwide Recall for Certain Lots of Cleviprex® That May Contain Particulate Matter

FOR U.S. AUDIENCES ONLY

Health and

HHS HealthBeat

(December 17, 2009)

Non-fighting words

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Accelerated approval process used in vaccine approval