Avandia controversy sparks FDA criticism

As anyone reading FierceHealthcare knows, diabetes drug Avandia came under heavy fire this week when a New England Journal of Medicine study suggested that it significantly raised the risk of heart failure. Now the expanding controversy has reached the FDA's doorstep. Consumer advocacy group Public Citizen has released an internal FDA memo from 2002 citing 25 Avandia-related heart failure cases, contending that the FDA's Center for Drug Evaluation and Research should have considered pulling the drug. The FDA memo cited by Public Citizen found that the drug class occupied by Avandia, thiazolidinediones, could be associated with heart failure in a way not reflected by product labels. Public Citizen says that the FDA should have followed reviewer recommendations and demanded listing of current reports on the drug.

To learn more about the controversy:
- read this United Press International piece

Related Article:
Avandia risks exposed under deal to post data. Report

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