Label Changes for:
Glucovance (glyburide and metformin HCl) tablets
November 2009
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Summary View November 2010
ADVERSE REACTIONS
Gastrointestinal
- In postmarketing reports cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glucovance should be discontinued if this occurs.
Summary View November 2009
*sulfonylurea agent class change
PRECAUTIONS
Glyburide
Hemolytic anemia
- Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Glucovance 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.
