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Posted at 02:28 PM ET, 02/28/2012

FDA updates statin safety guidelines


In this June 14, 2011 photo, the drug Lipitor is displayed at Medco Health Solutions Inc., in Willingboro, N.J. (Matt Rourke - Associated Press)
The FDA Tuesday issued updated safety labeling information for the class of drugs known as statins. The agency noted those drugs’ utility in reducing “bad” cholesterol “when used with diet and exercise” but fine-tuned guidelines for their use.

The new guidelines, aimed at health-care professionals, make it easier for patients to stay on statin therapy by eliminating the need for routine monitoring of liver enzymes. Liver disease among statin users is too uncommon and unpredictable, the agency notes, for such routine screening to be practical. Instead, patients should be screened for liver disease before starting statin therapy and then only if symptoms of liver disease (such as unusual fatigue or weakness, loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or the whites of the eyes) appear.

The statement also notes that some patients taking statins may experience memory loss or confusion, but that both those conditions resolve when statin use is discontinued. However, the FDA says, some studies show that statins slightly increase a patient’s risk of elevated blood-sugar levels and of developing type 2 diabetes.

Finally, the statement notes that one variety of statin drugs — lovastatin — may interfere with other medications and lead to muscle damage. Physicians should take care to read the new safety labels for those drugs when prescribing them, the statement says.

Statins include the following: 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).

In other statin news, research published online Feb. 21 in the Journal of Clinical Psychiatry found that people with coronary heart disease who take statins are at reduced risk of depression.

By  |  02:28 PM ET, 02/28/2012

 
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