FDA Knew Of Avandia Problem In 2002

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That’s what Public Citizen is alleging this afternoon in a letter the advocacy group wrote to FDA commish Andy von Eschenbach.

The evidence: a July 16, 2002, memo written by FDA scientists, who recommended that labels for Avandia and Actos, a similar drug, should include mention of post-marketing reports of heart failure among patients taking both meds. The label wasn’t changed, Public Citizen argues.

Specifically, the memo indicates that, at the time, the FDA had 47 adverse reaction reports in which the use of Avandia - 25 cases - and Actos - 22 cases - resulted in hospitalization for heart failure. As of last fall, the number of such cases had increased to 803 - 415 for Avandia and 388 for Actos. The total number of prescriptions filled for Avandia and Actos in 2006 was 22 million, or about 11 million for each drug, Public Citizen writes.

“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” wrote Sid Wolfe of Public Citizen. “As a result, millions of people - to the detriment of their health - are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.”

Here’s the letter to the FDA.
Here’s the 2002 FDA memo.[tags]Avandia, GlaxoSmithKline[/tags]

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