What are the FDA warnings for the use of statins?

Updated: Sep 19, 2019
  • Author: Richard Scott Lucidi, MD, FACOG; Chief Editor: Richard Scott Lucidi, MD, FACOG  more...
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Answer

On March 1, 2012, the US Food and Drug Administration (FDA) updated health care professionals regarding changes to the prescribing information concerning interactions between protease inhibitors (drugs for management of human immunodeficiency virus [HIV] and hepatitis B infection) and certain statin drugs. The combination of these drugs may raise the blood levels of statins and increase the risk for myopathy. Rhabdomyolysis, the most serious form of myopathy, can cause kidney damage and lead to kidney failure, which is life threatening. [66]

On February 28, 2012, the FDA approved important safety label changes for the class of cholesterol-lowering drugs known as statins, including removal of routine monitoring of liver enzymes. Information about the potential for generally nonserious and reversible cognitive side effects and reports of increased blood glucose and glycosylated hemoglobin (HbA1c) levels was added to the statin labels. In addition, extensive contraindication and dose-limitation updates were added to the lovastatin label in situations when this drug is taken with certain medications that can increase the risk for myopathy. [67]

On June 8, 2011, the FDA notified health care professionals of its recommendations for limiting the use of the highest approved dose (80 mg) of the cholesterol-lowering medication simvastatin (Zocor) because of increased risk of muscle damage. The FDA required changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medications. [68]


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