FDA Withdraws Approval of Niacin, Fenofibric Acid in Combination with Statins

In an unusual move, the Food and Drug Administration (FDA) has withdrawn earlier approval given for the use of niacin and fenofibric acid in combination with statins to treat high cholesterol.

The agency cited a lack of cardiovascular benefit in rescinding the approval for this treatment option, according to Medscape. The FDA announced the action in the Federal Register on April 18, 2016.

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.

Dr. Steven Nissen of the Cleveland Clinic called the FDA action “appropriate and important.” Nissen said, “There is no evidence for any meaningful benefit for addition of niacin or fibric acid derivatives to statins. There are also significant harms associated with these drugs. In the absence of benefits, there remain only harms. Unfortunately, these drugs continue to be prescribed to large numbers of patients. Hopefully FDA’s actions will significantly reduce inappropriate use,” according to Medscape.

Niacin can cause a variety of side effects—some serious—including flushing of the face and neck, headache, itching, burning, sweating, chills. Flushing may persist for a few hours after the medication is taken. Dizziness, stomach upset, heartburn, nausea, vomiting, and diarrhea may also occur. If any of these effects persist or worsen, the patient should speak with a doctor or pharmacist promptly, WebMD advises.

Niaspan received FDA approval in 1997 and was later indicated for use in combination with simvastatin or lovastatin for the treatment of high cholesterol and other fats in the blood when treatment with any of the three drugs was inadequate. Trilipix was approved in 2008 as an adjunct to diet in combination with a statin to reduce triglycerides and increase HDL cholesterol.

Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA determined 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,” the agency said in a notice filed in the Federal Register. The FDA used the same reasoning for withdrawing approval for Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin). AbbVie voluntarily pulled those products from the market at the end of 2015, Medscape reports.

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