Recommendations for monitoring felbamate during treatment of epilepsy

Felbamate (FBM) should only be used as add-on treatment for children age four and above and adults with severe epilepsies, especially in patients with Lennox-Gastaut-syndrome, who cannot be treated satisfactorily with other relevant anticonvulsants. Prior to prescribing FBM a careful history should be taken concerning haematological disorders including leuko- and thrombocytopenia, hepatic disorders, auto-immune disease and drug-induced exanthema. In addition, a blood count and liver function tests (SGOT, SGPT, bilirubin) should be performed. FBM should be given only after a very careful risk-benefit assessment in patients with clearly abnormal laboratory tests and a history of above mentioned disorders. Patients and relatives are to be informed about the risk of aplastic anaemia and acute hepatic failure and their early clinical signs and symptoms because laboratory monitoring will not reliably detect the early stages of clinical disease.