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FDA Approves Label Changes for Statins

Cognitive and blood sugar side effects added; recommendation of routine liver monitoring dropped

TUESDAY, Feb. 28 (HealthDay News) -- The recommendation to remove routine monitoring of liver enzymes is among safety label changes recently approved by the U.S. Food & Drug Administration for statins, according to a Feb. 28 Drug Safety Communication issued by the agency.

The safety label changes were approved upon a comprehensive review by the FDA of the cholesterol-lowering drugs. The labels now recommend testing liver enzymes before starting a patient on statins, and thereafter as clinically indicated, as liver injury with statins is rare and routine monitoring unwarranted.

In addition, the labels have been revised to include information on the potential for adverse cognitive effects, effects which are generally not serious and reverse quickly with discontinuation of the drug. Information on reports of raised blood sugar and glycosylated hemoglobin levels in patients taking statins has also been added to the labels. The lovastatin label has also been updated with new contraindications and dose limitations when it is taken with medications that can increase the risk for muscle injury.

According to the FDA, "based on all available data, [we have] determined that all currently marketed statins appear to be associated with a very low risk of serious liver injury and that routine periodic monitoring of serum alanine aminotransferase does not appear to detect or prevent serious liver injury in association with statins."

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