Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnsons Syndrome, dyspnea)
WARNINGS AND PRECAUTIONS
- There have been postmarketing reports of hypersensitivity reactions in patients treated with glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, promptly discontinue <insert drug name>, assess for other potential causes for the reaction, and institute alternative treatment for diabetes.
- Drugs Affecting Glucose Metabolism section edited
added the following bullet:
- Thrombocytopenia (including severe cases with platelet count less than 10,000/µL) and thrombocytopenic purpura
USE IN SPECIFIC POPULATIONS
- Duetact is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures, and urinary bladder tumor.
- Hemolytic Anemia - Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because DUETACT contains glimepiride which belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.