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U.S. Department of Health and Human Services

Safety

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Sulfonylurea Label Change

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2011

Summary View

 

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.