Health Canada updates safety information for Trileptal (oxcarbazepine)

August 5, 2011

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

Click here to see Canada Health’s complete advisory page

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