Felbamate.

The development and release of felbamate is characterized by several relatively unique features. Felbamate was submitted to innovative and unconventional clinical trials. It was the first antiepileptic drug (AED) to be tested in a double-blind fashion in patients withdrawn from AEDs for presurgical video/electroencephalogram (EEG) monitoring. In addition, felbamate was the first AED to be tested in double-blind monotherapy trials. Felbamate was also the first drug to be tested in a placebo-controlled trial in children with the Lennox-Gastaut syndrome. When it was first released in North America in 1993, felbamate was the first new antiepileptic drug in 15 years. Finally, after 1 year of being very successfully marked as a drug devoid of the adverse effects of other AEDs, felbamate came very close to being completely withdrawn from the market, because of several cases of fatal bone marrow aplesia and liver toxicity. At the present time, the main indication for felbamate is in children with Lennox-Gastaut syndrome, and similar forms of epilepsy, who failed to respond to other AEDs.