The Place of Felbamate in the Treatment of Epilepsy

Felbamate is one of a new generation of antiepileptic agents that has recently reached the market. In July 1993, it was approved for use in the US as an adjunctive and monotherapy in adults with partial seizures, with or without generalisation, and as adjunctive therapy in children with Lennox-Gastaut syndrome. However, the unexpected development of aplastic anaemia prompted the US Food and Drug Administration and the manufacturer, Carter Wallace, to issue a strong warning on 1 August 1994 regarding continued use of felbamate. Shortly thereafter, reports of felbamate-associated hepatic failure engendered further concern. As a result, felbamate is not indicated as a first-line treatment, but should be used only in those patients who respond inadequately to alternative treatments and whose epilepsy is severe enough that the risk of aplastic anaemia and/or liver failure is deemed acceptable by the patient compared with the benefits conferred by its use. Because of the effectiveness of this drug in many patients, felbamate will remain on the market in the US and may be available in certain situations in other countries.