Label Changes for:
Avandaryl (rosiglitazone maleate and glimepiride) tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009
WARNINGS AND PRECAUTIONS
- Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because glimepiride, a component of Avandaryl, 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 experience, hemolytic anemia has also been reported in patients receiving sulfonylureas who did not have known G6PD deficiency
What should I tell my doctor before starting Avandaryl?
- have glucose 6-phosphate dehydrogenase (G6PD) deficiency. This condition runs in families. People with G6PD deficiency who take glimepiride (one of the medicines in Avandaryl) may develop hemolytic anemia (fast breakdown of red blood cells).