News for May, 2007

FDA study said to show Avandia risk

The government’s own preliminary evaluation of the pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

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MedWatch 2007 Avandia

Avandia (rosiglitazone)
Audience: Endocrinologists, other healthcare professionals, consumers

Posted 05/21/2007 FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 mellitus using Avandia showed differing rates of ischemic cardiovascular events including or heart-related adverse events, some fatal, relative to other drugs used to treat mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with mellitus.

May 21st, 2007 by Staff with FDA