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Statin Labels Updated to Include Diabetes, Memory, and Drug Interaction Risks — Physician’s First Watch

Medical News |
February 29, 2012

Statin Labels Updated to Include Diabetes, Memory, and Drug Interaction Risks

The FDA is making several changes to the labels of statins following a comprehensive review, the agency announced on Tuesday:

  • Incident diabetes and increased blood glucose are possible with statin use. Several meta-analyses found an increased risk for diabetes (9%–13%) in patients taking statins.

  • Reversible memory loss and confusion are possible, though rare. The FDA said there is no evidence that these side effects lead to significant cognitive decline later.

  • Routine monitoring of the liver enzyme alanine aminotransferase is no longer required, although testing before statin initiation and as clinically indicated is still recommended. The agency has concluded that serious liver injury among patients taking statins is rare and cannot be prevented with routine monitoring.

  • Use of lovastatin is now contraindicated with strong CYP3A4 inhibitors — including itraconazole and erythromycin — to reduce the risk for rhabdomyolysis. Lovastatin's new label also lists dose limitations and several other drugs to avoid.

Reader Comments (2)

Deborah L Gordon

It is inconceivable to me that statins do not come with a "must supplement with coQ10 when prescribing this medication." CoQ10 is depleted with cholesterol and to far greater hazard. Why is this not standard of care?

Competing interests:

Thomas B. Kelly Pharm.D.

Were the likelihood of comorbidities in the statin taking population accounted for in the meta-analysis? It would seem many patients on statin therapy would have lifestyle and dietary factors that lend to increased blood glucose levels and diabetes.

Competing interests: None declared

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