FDA: GSK Failed to Report Avandia® Data

By Richard Seward

Published on April 10, 2008

In November, a warning about a serious risk of heart attack was added to the drug. Officials for the drug manufacturer claim the FDA had received all relevant information prior to the warning being issued. After an investigation conducted between August and November 2007, the FDA alleged that GlaxoSmithKline did not include several required post-approval studies in reports dating back to 2001.

In a letter to GlaxoSmithKline Chief Executive Office Jean-Pierre Garnier from March 25, the FDA expresses a concern that the violations it uncovered may be indicative of a wider pattern of noncompliance. A spokesperson for the drug maker claims the omissions were an oversight.

According to GlaxoSmithKline, the missing information included data concerning the start and progress of clinical trials in addition to reports on the final data culled from some of those trials. In a statement from the company's Chief Medical Officer, the reporting lapse did not affect the timely reporting of adverse effects of the drug.

The FDA ruled in November that Avandia® could remain on the market with a "black box" warning indicating the drug may increase the risk of heart attack.

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