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FDA adds diabetes, cognitive side effect risk warnings to statin labels

by Brendon Nafziger, DOTmed News Associate Editor | February 28, 2012
Revised labeling for statins no longer advises patients to undergo routine liver function tests but instead warns that some patients could be at a slightly increased risk to develop type 2 diabetes, hyperglycemia and reversible memory loss, the Food and Drug Administration said in an announcement Tuesday.

The FDA still recommends patients get liver function tests before starting statins, but says that serious liver injury is rare and unpredictable and would not be prevented through routine periodic monitoring. This recommendation is based on advice from two National Lipid Association research bodies, the FDA said on its website.

The new labels also include some new risks that have been reported in the literature. The FDA says there have been reports of mild cognitive effects such as memory loss and confusion, which generally clear up when patients stop taking the drugs, as well as increased blood sugar levels and slightly elevated diabetes risk.

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A 2010 meta-analysis published in the Lancet linked statins with a 9 percent increased risk for incident diabetes, the FDA said on its website.

The FDA also said that one particular statin, Mevacor (lovastatin), shouldn't be used with certain HIV medications and some other drugs because of an increased risk of muscle injury.

"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, a director with the FDA's Center for Drug Evaluation and Research, said in the announcement.

Statins are a widely prescribed class of drugs used to lower "bad" low-density lipoprotein (LDL) cholesterol levels.

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