New boxed warning for Avandia
NEWS IN BRIEF — Posted Dec. 10, 2007
The Food and Drug Administration announced Nov. 14 that Avandia's manufacturer, GlaxoSmithKline, has agreed to add new information to the boxed warning in the type 2 diabetes drug's labeling regarding potential increased risk for heart attack. GSK will also conduct a new, long-term study to evaluate the potential cardiovascular risk of Avandia, compared with an active control agent.
The revised warning notes that a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. The warning also notes that three other related studies have not confirmed or excluded this risk and that, in their entirety, the data on MI risks are inconclusive.
In a statement, GSK Chief Medical Officer Ronald Krall, MD, described Avandia as a valuable medicine that has a well-described and appropriate safety and effectiveness profile when used according to the label. "Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine."
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/12/10/hlbf1210.htm.