Postmarketing reports have shown that GABITRIL has been associated with new onset seizures and status epilepticus in patients without epilepsy. Dose may be an important predisposing factor in the development of seizures, although seizures have been reported in patients taking daily doses of GABITRIL as low as 4 mg/day. In most cases, patients were using concomitant medications (antidepressants, antipsychotics, stimulants, narcotics) considered to lower the seizure threshold. Some seizures have been observed near the time of a dose increase, even after periods of prior stable dosing.

In nonepileptic patients who develop seizures while on GABITRIL treatment, GABITRIL should be discontinued and patients should be evaluated for an underlying seizure disorder. Other important changes were added to the Pharmacokinetics, Overdosage, and Dosage & Administration sections of the P.I.

Cephalon is committed to educating healthcare professionals about these changes to the P.I. and to ensure the appropriate prescribing of GABITRIL.

As with other anticonvulsants in the treatment of epilepsy, GABITRIL should be withdrawn gradually to minimize the potential of increased seizure frequency unless safety concerns require a more rapid withdrawal.