MD warned in 2000 of risks from Avandia

A leading diabetes doctor sent the Food and Drug Administration a letter warning of the heart risks of the drug Avandia seven years ago. And the following year the FDA reprimanded the drug's maker for playing down safety concerns, according to documents from 2000 and 2001.

The documents, found in a reporter's search of the FDA's database, indicated that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug's maker, GlaxoSmithKline, was seeking to minimize Avandia's risks, before some of the same cardiovascular concerns were brought to public attention on Monday in a New England Journal of Medicine article and editorial.

The FDA has acknowledged that the company alerted the agency to concerns about a cardiovascular risk as early as 2005, based on the company's own analysis.

Glaxo has challenged the significance of the data cited in the medical journal. And, along with the FDA, the company has said it is too soon to draw conclusions that Avandia raises a Type 2 diabetes patient's risk of heart attacks. But the documents from 2000 and 2001 indicate that concerns about the drug's safety are by no means new.

The 2000 letter to the FDA was written by Dr. John B. Buse, chief of endocrinology at the University of North Carolina at Chapel Hill, who is about to become the president of the American Diabetes Association. His letter seven years ago sounded an alarm about Avandia, citing "a worrisome trend in cardiovascular deaths and severe adverse events" among patients using the drug.

In a telephone interview on Wednesday, Buse said that his opinion of Avandia had not changed since he wrote that letter. But he added Wednesday that regulators should not rush to judgment by withdrawing Avandia from the market.