Label Changes for:

Diabeta (glyburide) tablets

July 2009

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

CONTRAINDICATIONS

  • addition of patients with type 1 diabetes mellitus

WARNINGS

  •  “Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glyburide as well.”

PRECAUTIONS

people in whom hypoglycemia may be difficult to recognize
  •  “patients with autonomic neuropathy” 
drugs that may potentiate the hypoglycemic action of sulfonylureas
  • addition of ACE inhibitors, disopyramide, and fluoxetine 
  • “Rifampin may worsen glucose control of glyburide because rifampin can significantly induce metabolic isozymes of glyburide such as CYP2C9 and 3A4.”

ADVERSE REACTIONS

  • addition of language that cholestatic jaundice and hepatitis may progress to liver failure.
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