FDA Consumer Update: Statin Risks

Millions of Americans take statins for heart disease prevention. The FDA has released new important safety information regarding these cholesterol-lowering medications.

According to the FDA, some brain-related impairments, such as memory loss, forgetfullness and confusion has been reported by some statin users. The FDA also reports that statin users face a potential increased risk of higher blood sugar levels and the development of Type 2 diabetes.

The FDA will be updating the package insert of some statin products to communicate these new concerns.

The statin drugs affected are:

  • Altoprev (lovastatin extended-release)
  • Crestor (rosuvastatin)
  • Lescol (fluvastatin)
  • Lipitor (atorvastatin)
  • Livalo (pitavastatin)
  • Mevacor (lovastatin)
  • Pravachol (pravastatin)
  • Zocor (simvastatin)



The FDA has linked statin use with liver injury in rare cases.

Statin users experiencing any of the following symptoms should contact a health care professional:

  • unusual fatigue
  • loss of appetite
  • right upper abdominal discomfort
  • dark urine
  • yellowing of the skin or whites of the eyes



At this time the FDA believes that the heart benefit of statins outweighs the small increased risk of Type 2 diabetes and potential for muscle damage.

View the Full FDA Consumer Update

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