Eli Lilly Blood Thinner Approved, despite safety risks
The Food and Drug Administration approved a blood thinner from Eli Lilly, of Indianapolis, but the drug must have a black box warning of its risk of causing bleeding. The boxed warning is reserved for issues that can cause serious injury or death.
Lilly’s Effient is the first real competition to the blood thinner Plavix, which is made by Sanofi-Aventis and Bristol-Myers Squibb.
A Lilly study of more than 13,000 patients found that thought Effient prevented more heart attacks than Plavix, it caused more internal bleeding. Company studies showed 7 percent of patients taking Effient had nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death for the drugs were similar.
The FDA approval of Effient was 18 months long it weighed the drug’s benefits and risks.
Effient should not be taken by patients with a history of bleeding, stroke or who are undergoing an operation.
Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. Effient is approved only for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.
For more information please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm