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.
