FDA - MedWatch - Avandia (rosiglitazone) -Results Of An Ongoing Analysis of Safety Data Showed Differing Rates Of Ischemic Cardiovascular Events
May 22, 2007 07:44

Date: Mon, 21 May 2007 15:50:12 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA - MedWatch - Avandia (rosiglitazone) -Results Of An Ongoing Analysis of Safety Data Showed Differing Rates Of Ischemic Cardiovascular Events

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes. 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 diabetes mellitus.

Read the complete 2007 Safety Summary, including a link to the FDA News Release and Prescribing Information regarding is issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia

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