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WASHINGTON – In a fractured vote Wednesday, a significant number of members of an advisory committee for the Food and Drug Administration voted in favor of removing the controversial diabetes drug Avandia from the market in light of a reported increased risk of heart attack and other health problems.

The majority of the panel, however, voted to keep the drug on the market, albeit with stronger warnings on its labeling and possible restrictions to its sale.

After two days of testimony from experts, 12 members of the 33-member FDA advisory group voted in favor of withdrawing the drug from the market, while 10 voted in favor of restricting the sale of the drug and requiring labeling changes to warn of possible serious risks. Seven members voted only for labeling changes, while three recommended no change at all.

A final decision on Avandia will be made by the FDA in the future.

Safety concerns and studies showing a link between the drug and an increased risk of heart attack prompted the FDA to issue a safety advisory for Avandia in April of 2009.

Thousands of Avandia users who have suffered heart attacks and other serious injuries have filed suit against drug maker GlaxoSmithKline in state and federal courts.

The lawsuits accuse the company of aggressively marketing Avandia and failing to warn patients about the increased risk of heart attacks, heart failure and strokes.

The same day as the panel vote, Bloomberg News reported that GlaxoSmithKline agreed to settle the majority of the lawsuits, awarding each plaintiff an average of about $46,000 apiece. The deal apparently covers about 10,000 of the roughly 13,000 suits filed over the drug, according to the report.

Earlier news reports in June that thousands of Avandia cases had settled turned out to be incorrect, according to plaintiffs’ lawyers and the drug company.

Sen. Tom Harkin, D-Iowa, who chairs the Senate Committee on Health, Education, Labor and Pensions, urged the FDA to consider the panel’s recommendation and other expert testimony and studies carefully when making its final decision on the drug’s fate.

“Avandia is a widely used drug, and it is imperative that the risks associated with its use be properly understood and vetted,” said Harkin in a statement.  “I urge FDA to carefully consider today’s deliberations by the Joint Advisory Committee, and to make a final decision on how best to protect consumers as soon as possible. The safety of those suffering with diabetes must be our primary concern.”

Meanwhile, a group of physicians has sued the FDA seeking to compel the agency to alert patients to safe dietary alternatives to Avandia and other diabetes drugs that may pose a risk of heart attack, stroke and other complications.

The suit, filed in the U.S. District Court for the District of Columbia, accuses FDA commissioner Margaret Hamburg of failing to act on an administrative petition by the Physicians Committee for Responsible Medicine.

That petition urged the agency to require diabetes drugs to carry warning labels telling patients that low-fat plant-based diets can effectively treat type-2 diabetes without the dangerous side effects associated with oral medications.

“A plant-based diet is as effective as drugs for lowering blood sugar, and much more effective for trimming body weight,” says PCRM president Neal Barnard, M.D. “Doctors and patients need the facts.”

-Kimberly Atkins

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