Important changes have been made regarding warnings and precautions sections of the prescribing information for Oxcarbazepine ( Trileptal ).

Trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy.

Serious dermatological reactions, including Stevens-Johnson syndrome ( SJS ) and toxic epidermal necrolysis ( TEN ), have been reported in both children and adults in association with Trileptal use.
The median time of onset for reported cases was 19 days.
Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome.
Recurrence of the serious skin reactions following re-challenge with Trileptal has also been reported. Therefore, if a patient develops a skin reaction while taking Trileptal, consideration should be given to discontinuing Trileptal use and prescribing another anti-epileptic medication.

Multi-organ hypersensitivity reactions have occurred in close temporal association ( median time to detection 13 days: range 4-60 ) to the initiation of Trileptal therapy in adult and pediatric patients.
Although there have been a limited number of reports, 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 other organ system involvement.
Other associated manifestations included lymphadenopathy, hepatitis, liver function test abnormalities, haematological abnormalities ( e.g., eosinophilia, thrombocytopenia, neutropenia ), pruritis, nephritis, oliguria, hepato-renal syndrome, arthralgia and asthenia. If this reaction is suspected, Trileptal should be discontinued and an alternative treatment started. Although there are no case reports to indicate cross sensitivity with other drugs that produce this syndrome, the experience amongst drugs associated with multi-organ hypersensitivity would indicate this to be a possibility.

Source: FDA, 2005


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