Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for their combined use with statins to treat high cholesterol[1].
The decision affects niacin extended-release (Niaspan, AbbVie) and fenofibric acid (Trilipix, AbbVie), as well as AbbVie's Advicor and Simcor, both of which combine niacin with a statin.
FDA Pulls Approval of Niacin, Fibrate in Combo with StatinsBased on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events.
"Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets and fenofibric-acid [delayed-release] capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn," a document filed in the Federal Registry today states[1].
The same reasoning was cited for pulling its approval of Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin)[2]. Both drugs were voluntary pulled from the shelves at the end of 2015 by Abbvie.
Here's a link to a PDF of the official FDA notice that will appear in the Federal Register:
https://s3.amazonaws.com/public-inspect ... -08887.pdf
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