FDA announces label updates for statins to warn of diabetes risk

The FDA on Tuesday warned that patients taking statins may face a "small increased risk" of higher blood-sugar levels and of being diagnosed with type 2 diabetes. The agency, which took the action following a series of meta-analyses of studies examining the link, said that the labels of drugs in this class have been revised to warn of these risks.

The FDA also warned that certain cognitive effects have been reported with statin use and as such, labels for the drugs will now include information about some patients experiencing memory loss and confusion. However, this side effect will be listed as an "adverse reaction" rather than being put in the more serious warnings and precautions category.

In addition, the labels have been further revised to remove a requirement for routine periodic monitoring of liver enzymes in patients taking statins after it concluded that "routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect." Instead, the agency now recommends that liver enzyme tests be performed before starting statin therapy, and as clinically indicated thereafter.

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