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subject: What is next for Avandia law? [print this page]


The Food & Drug Administration advisory panel has made its recommendations about the controversial diabetes drug Avandia, but now the Food & Drug Administration must decide what to do about the drug, Lawyers and Settlements reports.

The FDA advisory panel has voted to keep the controversial diabetes drug on the market and impose stricter warnings after diabetes drug lawsuits have been filed. However, the FDA can choose to withdraw the product. Currently the FDA has ordered GlaxoSmithKline to stop enrolling patients in a comparison study, comparing the safety of Avandia to other diabetes drugs. Those who are currently enrolled in the trial can stay in it.

What Avandia law will be enforced next by the FDA is hard to determine. In 2007, the advisory panel also recommended the drug stay on the market, even though it was linked to a 43% higher risk of heart attack by a 2007 New England Journal of Medicine study.

GlaxoSmithKline, the diabetes drug maker, may have known about the increased risk of heart attacks because two days before meeting with the FDA, GlaxoSmithKline's Global Safety Board said Avandia studies agreed with previous studies of increased risk of heart attacks.

A week before meeting with the FDA, GlaxoSmithKline's head of research and development told the company's chief medical officer that Avandia patients were 30% to 43% more likely to suffer a restriction of blood supply. However, GlaxoSmithKline says the diabetes drug Avandia is safe and that the company has made information on possible health risks readily available.

The FDA can pull the controversial diabetes drug from the market if it says its risks are too great, or it could agree with the advisory panel and leave Avandia on the market. In the wake of all the Avandia lawsuits and Avandia settlements, what do you think the Food & Drug Administration should do?

If you or someone you know has ever suffered from Avandia drug injuries, the Avandia lawyers at Cofman Townsley Injury Lawyers can help.

What is next for Avandia law?

By: Alec Painter




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