Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Avandia debacle has prompted a safety official from the Food & Drug Administration (FDA) to call for changes in the way diabetes medications are approved for use in the United States. The FDA official, who reviewed the original approval application for Avandia, told the Journal of Diabetes Care that the safety and effectiveness of experimental diabetes medications should be tested against existing drugs before they are approved. If such a testing protocol were to be adopted by the FDA, it would mark a significant departure from the way most medications are granted approval in the United States.

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If you take the popular diabetes drug Avandia, you should take notice at the new warning label. The FDA has strengthened the warning label on Avandia to include an increased risk for heart attack. But it may be a little confusing. Officials say the warning label will say that Avandia “may or may not” increase their risk of heart attack.

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The government’s own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks 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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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 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 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 diabetes mellitus.

May 21st, 2007 by Staff with FDA