FDA Adds New Safety Warnings to Statin Labels

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The US Food and Drug Administration (FDA) announced that important safety changes will be made to the labeling of statins, according to a news release.

In reviewing the statin labels, the FDA concluded that serious liver injury with statin use is rare and unpredictable in individual patients and that routine monitoring of liver enzymes does not appear to be effective in detecting or preventing this side effect. Therefore, the FDA has decided to remove the need for routine periodic monitoring of liver enzymes in patients taking statins; it is now recommended that liver enzyme tests be performed before statin therapy is initiated and as clinically indicated thereafter. According to the news release, patients should contact their health care professionals immediately if they experience unusual fatigue or weakness, loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or whites of the eyes.

Additionally, statin labels will now include statements that some patients experience memory loss and confusion, as certain cognitive effects have been reported with statin use. The labels will also warn of the potential risk for increased blood sugar levels. Lastly, the FDA recommends that health care professionals take note of the new recommendations in the lovastatin (Mevacor) labeling, which warn of its potentially harmful interactions with other drugs, including those used to treat HIV and those used to treat certain bacterial and fungal infections.

“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Mary Parks, MD, of the FDA’s Center for Drug Evaluation and Research, said in the news release.

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