Associated Press reported that yesterday, FDA approved a blood thinner from Eli Lilly, even though this blood thinner has bleeding risks.
However, FDA has mandated that the drug must carry “the agency’s sternest warning because of its bleeding risks.”
Plavix is the world’s second best selling medication that will now have some competition with the approval of Lilly’s Effient. Plavix is made by Sanofi-Aventis and Bristol-Myers Squibb.
This decision to approve Effient has been delayed several times. FDA staffers reviewed Effient multiple times trying to weigh the drug’s risks versus its benefits.
Apparently, Effient has to carry a boxed warning to alert physicians of the risks of the bleeding and also is reserved for issues that may cause serious injury or death.
Lilly has conducted a study of over 13,000 patients with Effient. The results were that Effient prevents more heart attacks than Plavix; however, Effient causes more internal bleeding.
FDA said that Effient should not be taken by patients with a history of bleeding, stroke, or those patients who are undergoing surgery.
“Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire 2013.”
Do you think boxed warnings are effective?
Miller Tabak & Co. analyst Les Funtleyder says that “the boxed safety warning could curb sales, but not to a large extent. The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some meaning it had when it was rare.”