Harvard Heart Letter

FDA withdraws approval for two older cholesterol drugs

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In April, the FDA took the unusual move of withdrawing its approval for drugs that contain niacin or fenofibric acid when used in combination with a statin for lowering high cholesterol. The ruling affects four medications: extended-release niacin (Niaspan), extended-release niacin combined with lovastatin (Advicor) or simvastatin (Simcor), and fenofibric acid (Trilipix), as well as their generic counterparts.

The decision stems from several large clinical trials that showed no heart-related benefit from adding either niacin or fenofibric acid to a statin. Both drugs slightly raise high-density lipoprotein (HDL), a strategy once thought to be helpful but now considered of questionable benefit.

Niacin is also prescribed on its own to people who can't tolerate a statin and for those with high levels of blood fats known as triglycerides. But many people find niacin hard to take because of its side effects, which include nausea, vomiting, skin flushing, and dizziness. Fenofibric acid, which has milder side effects, is also prescribed for high triglycerides.

If you are currently taking either niacin or fenofibric acid, ask your physician if an alternative medication might be worth trying instead.