An expert panel convened to evaluate data and review current clinical practices regarding the novel
antiepileptic drug (AED)
felbamate.
Felbamate has demonstrated efficacy against a variety of refractory
seizures types, including
seizures associated with
Lennox-Gastaut syndrome, but postmarketing experience revealed serious idiosyncratic adverse effects that were not observed during clinical trials. Although
felbamate is not indicated as first-line
antiepileptic therapy, its utility in treating
seizures that are refractory to other AEDs is undisputed, as shown by the number of patients who continue to use it. New exposures to
felbamate number approximately 3200-4200 patients annually, and it is estimated that over the past 10 years, approximately 35,000 new starts have occurred. Recommendations by the American Academy of Neurology and a review of
felbamate literature were evaluated in conjunction with the clinical experience of the expert panel to determine current medical opinion and practice regarding
felbamate. The past 10 years of clinical experience have demonstrated that when used in accordance with existing recommendations and close clinical monitoring,
felbamate is an effective treatment for some patients with
seizures refractory to other AEDs. This review of clinical data and discussion of the current understanding of the risk:benefit of
felbamate therapy supports its use as an important therapeutic option for some patients with
refractory epilepsy.