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.