HEALTH

FDA takes action against Web sites selling unapproved, misbranded drugs

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Thursday completed a coordinated weeklong international effort, called the International Internet Week of Action, which is intended to curb illegal actions involving medical products.

During the effort, the FDA’s Office of Criminal Investigations, in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names.

“The FDA works in close collaboration with our regulatory and law enforcement counterparts in the United States and throughout the world to protect the public,” stated FDA Commissioner Margaret Hamburg. “Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.”

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Scientists closer to finding cause of IBD with new analyses

BY Michael Johnsen

PHILADELPHIA In the largest, most comprehensive genetic analysis of childhood-onset inflammatory bowel disease, an international research team has identified five new gene regions, including one involved in a biological pathway that helps drive the painful inflammation of the digestive tract that characterizes the disease.

A research team led by Hakon Hakonarson, director of the Center for Applied Genomics at The Children’s Hospital of Philadelphia, reported on Sunday that the findings advance the scientific understanding of how IBD develops.

“This is an evolving story of discovering what genes tell us about the disease,” stated Robert Baldassano, a co-first author of the study and director of the Center for Pediatric Inflammatory Bowel Disease at Children’s Hospital. “Pinpointing how specific genes act on biological pathways provides a basis for ultimately personalizing medicine to an individual’s genetic profile.”

The study appeared online Nov. 15 in Nature Genetics.

IBD is a painful, chronic inflammation of the gastrointestinal tract, affecting about 2 million children and adults in the United States. Of that number, about half suffer from Crohn’s disease, which can affect any part of the GI tract, and half have ulcerative colitis, which is limited to the large intestine.

Most gene analyses of IBD have focused on adult-onset disease, but the Center for Applied Genomics — one of the world’s largest pediatric genotyping programs — at Children’s Hospital has concentrated on childhood-onset IBD, which tends to be more severe than adult-onset disease. The researchers performed a genome-wide association study on DNA from more than 3,400 children and adolescents with IBD, plus nearly 12,000 genetically matched control subjects, all recruited through international collaborations in North America and Europe.

Some current IBD drugs are monoclonal antibodies that act on another cytokine, called tumor necrosis factor, which contributes to inflammation. Although much research remains to be done, the current study may provide a basis for developing drugs that target the cytokine IL-27’s action, for patients with the disease-causing gene variant.

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FDA: Anti-clotting drugs, PPIs may adversely affect each other

BY Alaric DeArment

ROCKVILLE, Md. Patients taking an anti-clotting drug should avoid the use of a drug for gastroesophageal reflux disease, the Food and Drug Administration warned Wednesday.

The FDA is advising patients using Bristol-Myers Squibb’s and Sanofi-Aventis’ Plavix (clopidogrel) to avoid taking prescription and OTC versions of AstraZeneca’s Prilosec (omeprazole) following data showing that Prilosec’s blocking of a certain liver enzyme may reduce Plavix’s anti-clotting effect by about 50%.

“Both of these drugs, when used properly, provide significant benefits to patients,” FDA Center for Drug Evaluation and Research Division of Cardiovascular and Renal Products scientist Mary Southworth said in a statement. “However, patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

Plavix is used to prevent blood clots that could lead to heart attacks or strokes. Prilosec, which belongs to the drug class known as proton-pump inhibitors and is available in branded and generic versions, is used to prevent such symptoms of GERD as heartburn. But Prilosec also blocks the liver enzyme CYP2C19, which Plavix needs to be metabolized. It is unknown how other proton-pump inhibitors may interact with Plavix.

The FDA based its decision on studies prompted by reports in January that use of Prilosec could diminish the effectiveness of Plavix.

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