Sunday, November 18, 2007

Avandia to be Labeled with New Warning

The FDA requested that GlaxoSmithKline (GSK), makers of Avandia (rosiglitazone), add new information to the existing warning on the drug's label. The new warning will address the potential increased risk for heart attacks. Last week, GSK agreed.

The revision of Avandia's existing boxed warning – FDA's strongest form of warning – includes the following statement:
"A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), 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. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive."
The FDA says Avandia will remain on the market while they continue their safety assessment. (FDA has requested, and GSK has agreed, that GSK conduct a new long-term study to evaluate Avandia's cardiovascular risk.)

FDA's press release:
FDA Adds Boxed Warning For Heart-Related Risks To Anti-Diabetes Drug Avandia

GSK's press release:
GlaxoSmithKline Revises US Labeling For Avandia