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FDA Panel to Weigh Revoking Key Use of Abbott Drug

May 18, 2011
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A panel of advisers to the Food and Drug Administration will consider whether to revoke a key indication from Abbott''s blockbuster cholesterol drug Trilipix, according to the Associated Press. 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 like Lipitor and Zocor, which lower bad cholesterol and are the most widely-used class of cholesterol drugs. But a 5,000-patient 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. The study was designed to show that the combination reduced heart attack, stroke and other deadly events in patients with Type 2 diabetes. The FDA will ask an outside panel to consider several options for Trilipix, according to documents posted online Tuesday. Those options include revoking the drug''s approval for use with statins, updating its label with information about the study, or simply leaving it on the market as is. The panel''s recommendation is not binding.

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