Statin Labeling Changes Include Class Warning About Glucose Effects
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Approach that “under conditions of safe use” would allow nonprescription access to some categories of Rx drugs for treating chronic conditions is among topics for FDA hearing on switching Rx products to behind-the-counter status or other alternative routes.
FDA appears to be taking steps to standardize new safety labeling across the statin class of cholesterol-lowering drugs.