FDA Alerts
FDA Announces Safety Changes In Labeling For Some Cholesterol-lowering Drugs
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor ( atorvastatin ), Lescol ( fluvastatin ), Mevacor ( lovastatin ), Altoprev ( lovastatin extended-release), Livalo ( pitavastatin ), Pravachol ( pravastatin ), Crestor ( rosuvastatin ), and Zocor ( simvastatin ). Combination products include: Advicor (...
(UPDATE 12/15) FDA Announces New Safety Recommendations For High-Dose Simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy , particularly during the first 12 months of use.