Label Changes for:
Lamictal (Lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets and Lamictal XR (Lamotrigine)
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) – August and November 2011, and August 2012
WARNINGS AND PRECAUTIONS
Multiorgan Hypersensitivity Reactions and Organ Failure
- Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with Lamictal…