Felbamate (FBM) should only be used as add-on treatment for children age fo
ur and above and adults with severe epilepsies, especially in patients with
Lennox-Gastaut-syndrome, who cannot be treated satisfactorily with other r
elevant anticonvulsants. Prior to prescribing FBM a careful history should
be taken concerning haematological disorders including leuko- and thrombocy
topenia, 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-b
enefit assessment in patients with clearly abnormal laboratory tests and a
history of above mentioned disorders. Patients and relatives are to be info
rmed about the risk of aplastic anaemia and acute hepatic failure and their
early clinical signs and symptoms because laboratory monitoring will not r
eliably detect the early stages of clinical disease.