Brand name and generic versions of statin drugs must carry these warnings on their labels, the FDA today announced.
The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
"We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol," Mary Parks, MD, director of the FDA's Division of Metabolism and Endocrinology Products, said in a news release.
The new labels will warn patients about:
There will also be a change in the current recommendation that patients on statins get routine liver tests. Those tests now will be needed only before starting statin treatment and then only as needed.
One statin drug, Mevacor, has been singled out for a special new warning. All statin drugs carry a small but serious risk of muscle injury. But this risk is particularly high for patients taking Mevacor and certain other drugs, including the protease inhibitor class of HIV drugs and some antibiotic and antifungal medications.