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Oxcarbazepine
Diagnosis & Treatment > Seizure Medications > Oxcarbazepine > Serious side effects of oxcarbazepine
 

Serious side effects of oxcarbazepine

SJS and TEN
As of April 19, 2005 the FDA and Novartis pharmaceuticals (the manufacturer of Trileptal) issued a new warning regarding oxcarbazepine. Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with oxcarbazepine use. The most common time of onset after first dosage of oxcarbazepine was 19 days. Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome.

The reporting rate of TEN and SJS associated with oxcarbazepine use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3 to 10 fold. 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. Therefore, if a patient develops a skin reaction while taking oxcarbazepine, consideration should be given to discontinuing oxcarbazepine use and prescribing another anti-epileptic medication.

Hyponatremia
Hyponatremia occurs more commonly with oxcarbazepine than with carbamazepine. While isolated cases of hyponatremic coma have been reported, oxcarbazepine-induced hyponatremia is seldom clinically significant.

Anaphylaxis and angioedema
Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with oxcarbazepine, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

  • Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
  • Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
    • Talking or thinking about wanting to hurt yourself or end your life
    • Withdrawing from friends and family
    • Becoming depressed or having your depression get worse
    • Becoming preoccupied with death and dying
    • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Reviewed July 2008 by Steven C. Schachter, MD, epilepsy.com Editorial Board.

When a patient presents with a serious and/or unexpected adverse reaction from a medication or device, you should consider reporting this event to Medwatch (http://www.fda.gov/medwatch/report/hcp.htm). To download Medwatch reporting forms click here (http://www.fda.gov/medwatch/getforms.htm).