Statin Labels Updated to Reflect Blood Sugar, Memory Side Effects

Statins, a class of drugs used by millions of people to lower their cholesterol, can raise blood sugar levels and may cause memory loss, the U.S. Food & Drug Administration (FDA) warned yesterday. The labels for the drugs are being updated to include information about these possible statin side effects, the agency said.

Drugs subject to the label change include:

  • • Lipitor (atorvastatin)
  • • Lescol (fluvastatin)
  • • Mevacor (lovastatin)
  • • Altoprev (lovastatin extended-release)
  • • Livalo (pitavastatin)
  • • Pravachol (pravastatin)
  • Crestor (rosuvastatin)
  • Zocor (simvastatin)
  • • Advicor (lovastatin/niacin extended-release)
  • • Simcor (simvastatin/niacin extended-release)
  • • Vytorin (simvastatin/ezetimibe)

In a statement released yesterday, the FDA said it was adding information about increases in blood sugar levels to statin labels, after studies indicated some patients have a small increased risk of experiencing this problem, and of being diagnosed with type 2 diabetes. The agency has also received reports of blood sugar levels increasing with statin use.

Certain cognitive (brain-related) effects have been reported with statin use, the FDA said. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur. Statin labels will now include information about some patients experiencing memory loss and confusion.

The FDA also said new recommendations would be added to the lovastatin products regarding contraindications and dose recommendations when they are used with other drugs that could increase the risk for muscle injury.

One recommendation that will be stricken from the drugs’ labels is the advice that patients taking statins undergo periodic live enzyme tests. The FDA said it 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. However, the agency also advised patients to notify their health care professional immediately if they have the experience symptoms of liver problems, including unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.

Statins rank among the best selling drugs in the world. According to a Reuters report, Lipitor is the world’s all-time biggest selling prescription medicine with cumulative sales of over $130 billion. In 2010, the generic version of Zocor, simvastatin, was the second most widely prescribed drug in the U.S.

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