WASHINGTON (January 15, 2014) A U.S. Food and Drug Administration expert advisory panel Wednesday recommended approval for an experimental blood thinner from Merck despite potentially serious side effects including internal bleeding.
The FDA’s panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.
Many analysts had written off the drug because of safety concerns.
Two large studies from Merck found that the drug significantly increased bleeding, including dangerous bleeding inside the skull, but the drug was limited to patients who had no history of strokes, it also helped reduce heart attacks, strokes and death.
Merck & Co. has asked the FDA to approve the drug for the narrower group of patients.