Global Drugs & Biologics Update

Asia/Pacific

PMDA – Pharmaceuticals and Medical Devices Agency

Lamictal Investigation concludes with alert to healthcare workers

The final investigation report on Lamictal recommends issuing an alert to healthcare professionals about the need to comply with the labeled instructions as to dosage and monitoring of patients to ensure against serious and possibly fatal skin reactions.  The four cases of fatal skin reactions were associated with off-label use of the drug.