Label Changes for:
Trileptal (oxcarbazepine) tablets and suspension
March 2011
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2011
PRECAUTIONS
Changes to Multi-Organ Hypersensitivity subsection
Hematologic Events
- Rare reports of pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with Trileptal during post-marketing experience. Discontinuation of the drug should be considered if any evidence of these hematologic events develop.
Pregnancy/Special Populations
- adds information regarding pharmacokinetics during pregnancy
Drug Interactions
- add cyclosporine to the list of drugs that have reduced plasma levels
ADVERSE REACTIONS
Postmarketing
- Hemic and Lymphatic System - Bone marrow depression, agranulocytosis, aplastic anemia, pancytopenia, neutropenia"
- Pancreatitis and/or lipase and/or amylase increase
- Metabolism and Nutrition Disorders - Folic Acid Deficiency
