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.