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July 25, 2008 11:44:26 AM CDT

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Diabetes Drug Given Strictest Warning Label

Posted Nov 14, 07 3:20 PM CST in Business,  Science & Health 

(Newser) – The FDA has applied its harshest warning to the diabetes drug Avandia, declaring the product potentially increases risk of heart attacks. Now marked with a “black box” warning, GlaxoSmithKline’s drug will stay on the market pending a continuing “safety assessment,” the Wall Street Journal reports; FDA officials say the agency remains split on the wisdom of pulling the drug immediately.

The Avandia controversy began with a May study showing the drug boosted heart-attack risk by 43%; US sales of the drug—$3 billion in 2006—have since dropped 50%. The FDA has asked Glaxo to run a long-term study comparing its product to a similar one called Actos. Both drugs already bear “black box” labels warning of heart failure risk.

Source Wall Street Journal

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David Barish, right, a 49-year-old Chicago attorney with diabetes and heart disease, talks with a members of his cycling club before a 50 mile ride Sunday, Sept. 9, 2007, in Evanston, Ill. Barish's doctors...   (Associated Press)
Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, left, watches as Food and Drug Administration Commissioner Andrew von Eschenbach testifies on Capitol...   (Associated Press)
MoneyWatch (CBS News)   (CBSNewsOnline (YouTube))
Food and Drug Administration Commissioner Andrew von Eschenbach testifies on Capitol Hill in Washington, Wednesday, June 6, 2007, before the House Oversight and Government Reform Committee hearing on...   (Associated Press)
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FDA  • diabetes  • GlaxoSmithKline  • Avandia  • black box  • Actos


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