In mid-April FDA withdrew its approval for statin use with niacin and fenofibric acid to treat high cholesterol.
In its summary, FDA noted that “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 in the risk of cardiovascular disease.”
Niacin extended-release (Niaspan) was first FDA-approved in July 1997. In 2009 the revised indication allowed for its use in combination with simvastatin and lovastatin to treat primary hyperlidemia and mixed dyslipidemia when monotherapy was not adequate.
In December 2008, FDA approved fenofibric acid (Trilipix) as an adjunct to diet combined with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are taking optimal statin therapy to achieve their LDL-C goal.
Evidence for FDA action
After reviewing the ACCORD, AIM-HIGH, and HPS2-THRIVE cardiovascular outcome studies, FDA determined that when niacin extended-release tablets and fenofibric acid delayed-release capsules are used with statins, the risks outweigh the benefits, and withdrew approvals for these indications.
The affected Niacin products include the reference product by Abbvie and seven generic products from the following companies, Barr, Lupin Ltd., and Sun Pharma Global.
The affected fenofibric acid products also include Abbvie’s reference product and three generic products by Anchen Pharmaceuticals, Lupin Ltd., and Mylan Pharmaceuticals.
"Introduction or delivery for introduction of these products with these indications in interstate commerce without an approved application is illegal and subject to regulatory action," the agency stated.