European regulators are gathering more info about Avandia safety. The European Medicines Agency convened an unexpected meeting of its advisory committee yesterday to discuss the diabetes drug, and that panel "identified a number of further questions" for drugmaker GlaxoSmithKline.
The agency didn't disclose just what those questions were, but said the answers were key to its review of Avandia safety. "The responses to these questions will help the Committee to reach its opinion on whether the marketing authorisations for rosiglitazone-containing medicines should be maintained, changed, suspended or revoked," EMA said in a statement. The Committee for Medicinal Products for Human Use will meet again Sept. 20-23 to decide Avandia's future.
The committee meeting comes on the heels of news that U.K. regulators have advised EMA to pull the drug. Drug watchdogs in Germany and Sweden are expected to weigh in as well. Meanwhile, FDA is due to decide how to proceed; that determination is expected next week. GSK maintains that the drug is safe when used according to its label.
- see the EMA release
- read the news from Reuters