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FDA Upgrades Rosiglitazone's Boxed Warning
Revised Language Warns of Added Heart-related Risks
By News Staff
"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."
Given that remaining uncertainty, the FDA has asked GSK to conduct an additional long-term study comparing rosiglitazone to an active control medication. GSK has agreed to do so, and the company also is developing a medication guide for patients that provides additional information about the benefits and risks of rosiglitazone use.
Related ANN Coverage
FDA Reviews Cardiovascular Risk Data for Rosiglitazone
(5/30/2007)
Additional Resources
FDA Nov. 14 News Release: "FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia"
FDA May 21 News Release: "FDA Issues Safety Alert on Avandia"
FDA Drug Information: Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
GlaxoSmithKline Update on Avandia
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