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Statin Labeling Changes Include Class Warning About Glucose Effects

 
• By Sue Sutter

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.

All cholesterol-lowering statin drugs will carry a uniform warning about the potential for increased blood sugar levels, pursuant to a class-wide labeling change announced by FDA Feb. 28.

The Warnings and Precautions section of all statin labels now includes a subsection on Endocrine Function with the following statement: “Increases in HbA1c and fasting serum glucose

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