Altoprev lovastatin XL regulatory update

FDA approved several label changes for the statin class of cholesterol drugs, including eliminating the need for routine periodic monitoring of liver enzymes. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. The agency concluded that serious liver injury with statins is rare and unpredictable, and that routine monitoring of liver enzymes does not appear to be effective in detecting or preventing the side effect.

Additionally, the labels now include information about certain cognitive effects, including memory loss and confusion, and hyperglycemia that have been reported with statin use. FDA specifically updated the label Mevacor lovastatin from Merck to warn about the risk of muscle injury when used with certain other medicines, including protease inhibitors to treat HIV infection and products for certain bacterial and fungal infections. ...