FDA Changes Statin Labeling

The Food and Drug Administration (FDA) has approved important safety label changes for the class of statin drugs. The changes include:

  • Routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, is no longer needed. Such monitoring has not been found to be effective in predicting or preventing the rare occurrences of serious liver injury associated with statin use.
  • Information about the potential for generally non-serious and reversible cognitive side effects, such as memory loss, forgetfulness and confusion.
  • New labeling will note that people being treated with statins may have an increased risk of increased blood sugar and glycosylated hemoglobin (HbA1c) levels (type 2 diabetes).

While the move is a class change, 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.

To link to a summary of the label changes, click here.

As to the rationale for the changes, the FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.

The changes also reflect rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

This new information should not scare people off statins, said Amy G. Egan, MD, MPH, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP). “The value of statins in preventing heart disease has been clearly established,” she says. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

FDA will be changing the package inserts of popular statin products, including 

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

Products containing statins in combination with other drugs include:

  • Advicor (lovastatin/niacin extended-release)
  • Simcor (simvastatin/niacin extended-release)
  • Vytorin (simvastatin/ezetimibe).

Clinical Topics: Sleep Apnea

Keywords: Hemoglobin A, Glycosylated, Cognition, Product Labeling, Confusion, Diabetes Mellitus, Type 2, Memory Disorders

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