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FDA Issues Label Change for Statins

The U.S. Food and Drug Administration (FDA) has approved safety label changes for statins, which include eliminating the requirement for routine monitoring of liver enzymes from the drug labels and adding information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and HbA1c levels.

Also, the label for lovastatin has been updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury. Health care professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.

“The updated FDA statin label serves as an appropriate reminder to patients and physicians about the relatively rare and reversible known side effects associated with these important medications,” said ACC CEO Jack Lewin, MD. “While it is important to recognize the side effects sometimes associated with statins, it is also important to emphasize that the powerful benefits of statins far outweigh the risks for the vast majority of patients."

The FDA continues to recommend health care professionals perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter.

Read the complete FDA alert here.