FDA Looks To Standardize New Hepatic Warnings For Statins
Executive Summary
FDA appears to be taking steps to standardize new safety labeling across the statin class of cholesterol-lowering drugs.
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Statin Labeling Changes Include Class Warning About Glucose Effects
All statin labels now warn that “increases in HbA1C and fasting serum glucose levels have been reported” with the cholesterol-lowering drugs. Labels also reflect a relaxation of hepatic monitoring requirements, which could remove one hurdle to Pfizer’s pursuit of an OTC switch for Lipitor.
Statin Labeling Changes Include Class Warning About Glucose Effects
All statin labels now warn that “increases in HbA1C and fasting serum glucose levels have been reported” with the cholesterol-lowering drugs. Labels also reflect a relaxation of hepatic monitoring requirements, which could remove one hurdle to Pfizer’s pursuit of an OTC switch for Lipitor.
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