Diabetes Drug Given Strictest Warning Label

FDA's 'black box' adds risk of heart attack to concerns on Avandia
By Jonas Oransky,  Newser Staff
Posted Nov 14, 2007 3:20 PM CST
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)
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(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.