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 risk of serious dermatological reactions, including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), as well as multi-organ hypersensitivity reactions in both children and adults, associated with the use of Trileptal (oxcarbazepine)."
Revised safety information concerning the risk of Trileptal includes:
Life Threatening Dermatological Reactions
· "Serious dermatological reactions, including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with the use of TRILEPTAL.
· The reporting rate of SJS and TEN with use of TRILEPTAL currently exceeds the background incidence rate estimates by a factor of 3-10 fold. Some patients have required hospitalization with very rare reports of fatal outcome. Most cases occurred within the first month. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.5 to 6 cases per million person years.
· If a patient develops any skin reaction while taking TRILEPTAL, consideration should be given to discontinuing Trileptal use and prescribing another anti-epileptic. A diagnosis of SJS or TEN requires immediate discontinuation of TRILEPTAL."
Multi-Organ Hypersensitivity
· "A limited number of cases of multi-organ hypersensitivity reactions have been reported in both children and adults in association with the use of TRILEPTAL. Many of these cases resulted in hospitalization and some were considered life threatening.
· Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with various organ system abnormalities, including liver, kidney and hematological. Other organ symptoms and signs may occur.
· If this reaction is suspected, TRILEPTAL should be discontinued immediately and an alternative treatment started."
Cross-sensitivity with Carbamazepine
· "Approximately 25-30% of patients who have had hypersensitivity reactions to carbamazapine will experience hypersensitivity reactions with TRILEPTAL. Hypersensitivity reactions may also occur in patients without a history of hypersensitivity to carbamazapine."
Source: Health Canada. "Therapeutic Products Directorate: TPD-Web."
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