FDA Pulls Approval of 2 Drugs Used in Combination with Statins

The FDA has withdrawn approvals for the administration of niacin and fenofibric acid in combination with statins for the treatment of high cholesterol, citing a lack of cardiovascular benefit.

The FDA originally approved extended-release niacin in 1997, followed by a revised indication in 2009, approving niacin for use in combination with simvastatin or lovastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia.
__________________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
Niacin May Increase Risk of Adverse CV Events
Niacin Decreases Death Risk for Kidney Patients
__________________________________________________________________________________________________________________________________________________________________

The decision to pull the approvals was based on the collective evidence from several large cardiovascular outcome trials, (ACCORD, AIM-HIGH, and HPS2-THRIVE). They wrote 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 in the risk of cardiovascular events.”

For this reason, they determined that the benefits of these treatment options no longer outweigh the risks, and that the approvals should, therefore, be withdrawn.

—Michael Potts

Reference:

US Food and Drug Administration. Withdrawal of approval of indications related to the coadministration with statins in applications for niacin extended release tablets and fenofibric acid delayed release capsules. https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-08887.pdf. Accessed April 18, 2016.