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
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