FDA Withdraw The Approval of Niacin and Fenofibric Announced in the Federal Register on April 18, 2016, the U.S. Food and Drug Administration (FDA) disclosed their decision to withdraw earlier approval of niacin and fenofibric acid in combination with statins to treat high cholesterol, according to Medscape.
Affected are niacin extended-release (Niaspan, Abbvie), and fenofibric acid (Triliplix, Abbvie) along with Abbvie’s Advicor and Simcor, both of which combineniacin with a statin. Niacin, or Vitamin B-3, are important for overall good health and in higher doses help improve cholesterol levels. Statins are any of a group of drugs that inhibit the synthesis of cholesterol and promote production of LDL-binding receptors in the liver, reports WebMed.
the collective evidence from several large cardiovascular outcome trials
“Based on the collective evidence from several large cardiovascular outcome trials, the agency has concluded that the totality of the 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 of cardiovascular events,” the FDA said. The agency also concluded that benefits of certain niacin combined with statin medications no longer outweigh the risks and approval should be withdrawn, Law360 reports.
Possible niacin side effects include flushing of the face and neck, headache, itching, burning, sweating, and chills. Flushing may persist for several hours after the medication is taken. Stomach upset, dizziness, heartburn, nausea, vomiting, and diarrhea may also happen. A doctor or pharmacist should be consulted if any of these effects persist or worsen, advises WebMed.
By the end of 2015, both Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin were voluntarily removed from shelves by the drug company, Abbvie, MedScape reports.