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Diagnosis & Treatment > Seizure Medications > Gabitril® > Serious side effects of Gabitril
 

Serious side effects of Gabitril

A review of 53 clinical trials involving nearly 3,100 patients treated with Gabitril found no clinically important effects on laboratory tests, hepatic metabolism, or concomitant AEDs. There has been no evidence of the development of visual field loss in patients taking Gabitril.

As of August, 2003, there had been over 39,000 patient-years of exposure to Gabitril. Case reports have attributed thrombocytopenia, convulsive status epilepticus, and reversible acute dystonic reactions to Gabitril.

Numerous reports have documented confusional states or nonconvulsive status epilepticus (NCSE) in patients with partial-onset or generalized seizures, including one patient with psychogenic nonepileptic seizures. Remission has been reported with decreases in the daily dose of Gabitril, or with clonazepam (Klonopin) or lorazepam (Ativan). The incidence of symptoms consistent with NCSE in blinded trials was no higher in patients who received Gabitril than in those who received placebo, however. Since status epilepticus occurs in 5-10% patients with refractory seizures, the significance of these findings is unclear.

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).