Health Canada Endorsed Important Safety Information on TRILEPTAL (oxcarbazepine): Association of TRILEPTAL (oxcarbazepine) with life-threatening dermatological reactions and multi-organ hypersensitivity
In April 2005, Novartis Pharmaceuticals Canada Inc. distributed a letter to Canadian healthcare professionals concerning the updated consumer information for Trileptal tablets and oral suspension. Trileptal is used as a monotherapy or adjunctive therapy to treat partial seizures in adults and children ages six to 16 with epilepsy.
Revised safety information concerning the risk of Trileptal includes:
- life-threatening dermatological reactions including
- Stevens Johnson Syndrome (SJS)
- toxic epidermal necrolysis (TEN)
- multi-organ hypersensitivity
- cross-sensitivity with carbamazapine