EU Drug Panel Starts Review Of Rosiglitazone-Containing Medicines

9th Jul 2010 10:13

LONDON (Dow Jones)--The European Medicines Agency said Friday it has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile. MAIN FACTS: -The review by the Agency's Committee for Medicinal Products for Human Use follows the recent publication of further studies on the cardiovascular safety of rosiglitazone. -Rosiglitazone on its own is authorized in the E.U. as Avandia, in combination with metformin as Avandamet and with glimepiride as Avaglim. -At the time of their authorization, these medicines were contra-indicated in patients with heart failure or a history of heart failure. -Since then, the product information has been updated to include warnings and contra-indications on the use of these medicines in patients with heart problems. -In 2008, the CHMP concluded that on the basis of the available evidence and with the restrictions in place, rosiglitazone retained a small, if diminishing, place in diabetes type 2 therapy. -The Committee is now assessing the new data. -Once all relevant data on the benefits and the risks of rosiglitazone have been looked at, the CHMP will issue an opinion on whether or not the marketing authorizations for these medicines should be revoked, suspended or changed. -By Tommy Stubbington, Dow Jones Newswires; 44-20-7842-9268; [email protected] (END) Dow Jones Newswires July 09, 2010 05:13 ET (09:13 GMT)