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Drug & Device News

By ALM Staff | Law Journal Newsletters |
June 28, 2007

Diabetes Drug Increases Heart Attack Risk

The Food and Drug Administration (FDA) issued an alert May 21 after non-FDA affiliated researchers reported that the Type 2 diabetes drug Avandia' (rosiglitazone maleate) has been shown to increase heart attack risk. Avandia is manufactured by GlaxoSmithKline PLC and has been on the market for eight years.

The researchers discussed the findings of their study of pooled safety data in the New England Journal of Medicine, using their findings to criticize the FDA's methods for determining the risk/benefit ratio of a new drug and the agency's post-market drug safety monitoring procedures. Nissen, Stephen E. and Wolski,
Kathy, Published at www.nejm.org May 21, 2007 (10.1056/NEJMoa072761). Although the FDA issued the alert following the NEJM publication, it pointed out in its public comment that the agency has made no new assessment of its own concerning the safety of Avandia and is not now recommending that patients be switched to different drug products, as such changes in treatment can lead to their own complications. For further information, see the FDA Alert at: www.fda.gov/Cder/drug/infopage/rosiglitazone/default.htm
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