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FDA Approves Label Changes for Statins

From UPI Health News (Business) (February 28, 2012)

The U.S. Food and Drug Administration approved safety label changes for statins -- a class of cholesterol-lowering drugs known as statins, officials said.

Statins, along with diet and exercise, reduce blood levels of low-density lipoprotein, the "bad" cholesterol, and are marketed as a single products as Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor and Zocor. They are also marketed as combination products, including Advicor, Simcor and Vytorin.

Based on the FDA's review of the statin class of drugs the changes include:

-- Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins and now recommend that liver enzyme tests be performed before starting statin therapy and as clinically indicated thereafter.

-- Information about the potential for generally non-serious and reversible cognitive side effects such as memory loss and confusion, and reports of increased blood sugar and glycosylated hemoglobin levels have been added to the statin labels because the FDA said cardiovascular benefits of statins outweigh these small risks.

-- The lovastatin label has been extensively updated with new situations when the drug should not be used and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.

-- In some individuals age 50 and older experienced notable, but ill-defined memory loss or impairment that was reversible after discontinuation of statin therapy. The cases did not appear to be associated with fixed or progressive dementia, such as Alzheimer's disease.
 

Posted: February 2012


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