FDA panel to weigh revoking key use of Abbott drug
WASHINGTON (AP) — A panel of advisors to the Food and Drug Administration will consider this week whether to revoke a key indication from Abbott's blockbuster cholesterol drug Trilipix.
Trilipix is a fibrate, a drug that lowers blood fats called triglycerides while boosting "good" cholesterol. The drug is approved for combination use with statins, the most widely-used class of cholesterol-lowering drugs.
But a large government study released in March showed that diabetic patients taking Trilipix plus a statin had just as many heart attacks as patients taking a statin alone.
On Thursday, the FDA will ask an outside panel to consider several options for Trilipix, including revoking its approval for use with statins, or simply adding information to its label about the results of the study. The panel's recommendation is not binding.