Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol. The decision affects the indication of niacin extended-release and fenofibric acid, both of which combine niacin with a statin. Niacin was first approved for several indications by the FDA in 1997 and later indicated in combination with simvastatin or lovastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia when monotherapy with any of the three drugs was inadequate.
Fenofibrate first gained FDA approval in 2008 for several indications and was indicated as an adjunct to diet in combination with a statin to reduce triglycerides and increase HDL cholesterol in patients with mixed dyslipidemia and CHD or a CHD risk equivalent. Based on several large cardiovascular…
