The U.S. Food and Drug Administration (FDA) has decided to require that the agency’s strongest health warning be added to labeling for the diabetes drugs Avandia and Actos, according to a New York Times article. According to the Times, due to concerns over heart risks associated with the diabetes medications, “the agency was asking the makers of Actos and Avandia to carry a more prominent warning of its heart risks because ‘despite existing warnings, these drugs were being prescribed to patients with significant heart failure.’” Word of the decision came from FDA Commissioner Andrew C. von Eschenbach, during a U.S. House of Representatives Committee on Oversight and Government Reform hearing discussing potential FDA reform.
- NY Times article: FDA Calls for New Warnings on Diabetes Drugs
- Diabetes Drug Linked to Heart Disease (Common Law Blog 5/21/07)
- FDA Safety Alert on Avandia (May 21, 2007)
- Avandia Health and Legal Information
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