Pérez-Miranda J, Aguirre J, Parrilla J L, Pérez Miranda M
Facultad de Medicina, Universidad de Extremadura, Badajoz.
Rev Neurol. 1995 Nov-Dec;23(124):1220-5.
The present work is a review of the new anti-epileptic drug felbamate. Felbamate is a dicarbonate with antiepileptic effects in partial attacks and in Lennox-Gastaut syndrome. This new drug is especially interesting since its pharmacological action on test animals would indicate a wider anti-epileptic spectrum of activity than most other such drugs. We review the clinical pharmacology of felbamate, its development as a new antiepileptic and the new clinical control type trials carried out into epilepsy. We also give a summary of clinical trial experiments performed using felbamate in the treatment of partial refractory attack and of Lennox-Gastaut syndrome. Felbamate has turned out to be the first anti-epileptic with specific efficacy in Lennox-Gastaut syndrome. Felbamate was approved as an anti-epileptic by the United States Food And Drug Administration in July 1993 for clinical use with children suffering from Lennox-Gastaut syndrome and with adults having partial epileptic attacks. 1994 saw some cases of aplastic anaemia and liver failure associated with treatment using felbamate which called for a reevaluation of the benefit-risk factors of the drug. Its use in the European Union was restricted to Lennox-Gastaut syndrome, and rigorous liver function and haematological controls were set up in patients so treated. In the United States the FDA also allows treatment using felbamate of partial attacks not responding to any type of medicine.