FDA warns drug company over Avandia studies

updated 12:02 p.m. ET April 8, 2008

WASHINGTON - Federal regulators have issued a warning to GlaxoSmithKline for not reporting safety results on its diabetes pill Avandia, which received a prominent warning label last year.

The Food and Drug Administration said that between 2001 and 2007 the drug maker did not update the agency on more than 10 ongoing studies of Avandia, as required by regulations.

While FDA acknowledges information from the studies was disclosed in other notices to the government, the omissions “are serious and may be symptomatic of underlying post-market reporting failures.”

FDA posted the warning letter, dated March 25, to its Web site Tuesday.

Last November, Avandia received a black box warning, the most serious a drug can carry. The labeling alerts doctors and patients that the drug could increase the risk of heart attacks, though the evidence is inconclusive.

Glaxo has agreed to FDA’s demand for a major study directly assessing Avandia’s heart effects. The study won’t be complete until 2014.

The labeling change followed several high-profile congressional hearings where FDA and Glaxo were criticized for not disclosing the drug’s potential risks earlier.

A spokeswoman for Glaxo said Tuesday the agency had all safety studies on Avandia before it added the black box warning last year. The company is working with FDA to resolve the issues, she added.

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