Label Changes for:
Micronase (glyburide) tablets
February 2011
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2011
Risk of Hepatic Failure Label Changes for Sulfonylurea's
- Diabinese (chlorpropamide) tablets
- Micronase (glyburide) tablets
- Metaglip (glipizide/metformin HCl fixed-dose combination) tablets
- Glucotrol and Glucotrol XL (glipizide) tablets
- Glynase (micronized glyburide) tablets
ADVERSE REACTIONS
- Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; The drug should be discontinued if this occurs.
