July 27, 2007

An FDA advisory committee will meet on Monday to evaluate evidence of an increase in heart attack risk for patients taking the diabetes drug Avandia. The Times reports today that a preliminary report by FDA reviewers seems to reinforce concerns:

Patients who take Avandia, a popular diabetes medicine, face an increased risk of heart attacks while those who take Actos, a similar drug, do not, federal drug reviewers conclude in a new report.
Avandia, made by GlaxoSmithKline, is particularly dangerous to patients who take insulin, the review found, a risk not found with Actos, made by Takeda.

The drugs, which increase the body's sensitivity to insulin, were each taken by about one million patients last year. The Food and Drug Administration should issue strict warnings about Avandia's heart attack risk, the reviewers concluded. On Monday, the agency is planning to ask an independent panel of experts whether they agree with stronger warnings or want the drug removed from the market.

"A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit of rosiglitazone outweighs the demonstrated cardiovascular risk," one agency reviewer concluded, referring to Avandia by its generic name.

The only certainty at this point is that plaintiff's lawyers are lining up clients to sue GSK - and that the FDA's reputation is taking another blow at a time when it can ill afford it.

Posted by Paul Howard at July 27, 2007 12:01 PM

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