FDA Expands Advice on Statin Risks
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Liver Injury
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Reports of Memory Loss
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The Risk of Diabetes
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The Potential for Muscle Damage
If you’re one of the millions of Americans who take statins to prevent heart disease, the Food and Drug Administration (FDA) has important new safety information on these cholesterol-lowering medications.
FDA is advising consumers and health care professionals that:
- 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.
- Cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users.
- People being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes.
- Some medications interact with lovastatin (brand names include Mevacor) and can increase the risk of muscle damage.
This new information should not scare people off statins, says Amy G. Egan, M.D., M.PH., 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.”
