What FDA warnings exist for medications used in the treatment of polycystic ovarian syndrome (PCOS)?

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

FDA safety alerts

Statins

On March 1, 2012, the US Food and Drug Administration (FDA) notified health care professionals of updates 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. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

On February 28, 2012, the FDA approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood glucose and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.

On June 8, 2011, the FDA notified health care professionals that it recommended limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) 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 medicines.

Sibutramine

On October 8, 2010, Abbott Laboratories and the FDA notified health care professionals and patients about the voluntary withdrawal of sibutramine (Meridia), an obesity drug, from the US market because of clinical trial data indicating an increased risk of heart attack and stroke.


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