FDA Withdraws Approval of Four Cholesterol Drugs

Friday, April 29, 2016
FDA Recalls

The U.S. Food and Drug Administration took the unusual step this week of withdrawing its approval of four medications used to treat high cholesterol, based on studies that show the benefits of the drugs no longer outweighed the risks.

The change will affect drugs containing niacin, also known as vitamin B-3, and/or fenofibric acid, when the medications are combined with statins.

All of the drugs affected are sold by pharmaceutical giant AbbVie. They include Niaspan, an extended-release form of niacin; Advicor and Simcor, combination drugs of niacin and statins; as well as Trilipix, a fenofibric acid formulation.

While Advicor and Simcor were voluntarily recalled by AbbVie at the end of 2015, Niaspan and Trilipx remain on the market.

The FDA first approved Niaspan in 1997 and Trilipix in 2008 for individual use, but later added indications to both drugs that they could be prescribed along with statins to treat high cholesterol.

In its decision, the FDA cited the results of numerous studies, including HPS2-THRIVE, ACCORD and AIM-HIGH, that found using medications to reduce triglyceride levels while increasing HDL-cholesterol levels did not reduce the overall risk of cardiovascular injury in patients.

The agency stated: "Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets and fenofibric-acid [delayed-release] capsules for co-administration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn."

The decision does not affect the use of Niaspan or Trilipix as individual drugs, only their use in combination with a statin.

Any patients taking the affected medications are urged to contact their doctor immediately, but should not stop taking any medication before talking with their doctor first.

DrugNews will continue to monitor the FDA for any new decisions concerning these drugs. For more information, contact one of our patient advocates today.



Wendling, P. FDA Pulls Approval of Niacin, Fibrate in Combo with Statins. MedScape. (April 15, 2016). Retrieved from www.medscape.com

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