FDA Adds Safety Warnings to Statins

TUESDAY Feb. 28, 2012 -- The popular cholesterol-lowering drugs called statins will now come with revised labels warning of a slight increased risk of elevated blood sugar levels, which could lead to type 2 diabetes, as well as a warning on rare cases of confusion and memory loss, U.S. drug regulators said Tuesday.

But the U.S. Food and Drug Administration, which made the announcement, and health-care professionals all stressed that the heart-protective benefits of statins -- which include drugs such as Crestor, Lipitor, Pravachol and Zocor -- far outweigh the risks spelled out on the new labels.

"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," Dr. Mary Parks, director of the FDA's Division of Metabolism and Endocrinology Products, said in a news release.

Dr. Gregg Fonarow, professor of cardiovascular medicine at the University of California, Los Angeles, and a spokesman for the American Heart Association, agreed with the FDA. "The benefits of statin medications for most individuals exceed the potential risks," he said.

Statins have been very effective in lowering cholesterol and the potential risk of fatal and non-fatal cardiovascular events for men and women with established heart disease, as well as for otherwise healthy individuals with one or more cardiovascular risk factors, he said.

The labeling changes reflect recent data from statin clinical trials and occasional side effects that have been reported, Fonarow added.

The full list of statins 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), the FDA said.

The FDA also said it was removing from the label the need for routine monitoring of liver enzymes. The agency now recommends that these tests be done before patients start statin therapy, and as indicated thereafter.

The FDA says serious liver injury with statins is "rare and unpredictable," and "routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect."

There have been sporadic reports from patients using statins of memory loss and confusion. The drug label will now include information about these potential side effects.

"These reports generally have not been serious and the patients' symptoms were reversed by stopping the statin," the FDA noted.

In addition, the FDA said doctors need to be aware that one statin -- lovastatin (Mevacor) -- can interact with other drugs, increasing the risk for muscle injury. Those other drugs include protease inhibitors, which are used to treat HIV, and drugs used to treat some bacterial and fungal infections, the agency said.

More information

To learn more about statins, visit the U.S. National Library of Medicine.

Posted: February 2012


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