Lamictal Approved as Adjunctive Therapy for Grand Mal Seizures

The FDA has approved the use of the antiseizure drug Lamictal (lamotrigine) as an adjuvant treatment of primary generalized tonic-clonic seizures.

Lamictal was already approved for the treatment of several other types of epilepsy (partial seizures and the generalized seizures of Lennox-Gastaut syndrome) and as maintenance therapy in patients with bipolar disorder.

The latest approval was based on a placebo-controlled trial of 117 patients already receiving one or two antiepileptic drugs. The frequency of primary generalized tonic-clonic seizures decreased by a median of 66% in the Lamictal group compared with 34% in the placebo group.

Lamictal is approved for use in adults and in children aged 2 years and older. The drug carries a black-box warning about the risk for serious rashes, including Stevens Johnson syndrome, associated with its use. Other side effects appear to be relatively infrequent and include dizziness, drowsiness, and nausea.