Label Changes for:
Lamictal (Lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets and Lamictal XR (Lamotrigine)
August 2012
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
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…
