Ensuring drug safety: lessons from the thiazolidinediones

Abstract

An editorial that accompanied the paper, while acknowledging the findings' "fragility", called for urgent regulatory action; GSK vigorously defended its product, saying that studies show Avandia's cardiovascular profile to be comparable to other oral antidiabetes agents; and this journal counselled against a rush to judgment, advising patience until the final results of RECORD, a phase III trial designed to assess cardiovascular outcomes, were available. The FDA meeting resulted in a 22 to 1 vote to keep Avandia on the market, and to add a "black box" warning on the label of the risks of the drug's use in patients with congestive heart failure.