Authors: Bowden CL, et al. Title: Safety and tolerability of lamotrigine for bipolar disorder. Reference: Drug Safety 2004;27:173-84. Purpose: To review the tolerability and safety of lamotrigine as a first-line treatment for acute depression in bipolar disorder and maintenance therapy. Study design: Review of eight placebo-controlled clinical trials of lamotrigine including data from four unpublished studies. Follow up: Not applicable. Patients: Almost 1,800 patients with bipolar disorder, with 827 patients given lamotrigine as monotherapy or adjunctive therapy. Treatment: In the placebo-controlled trials, a mean dose of lamotrigine 146 ± 114 mg/day was used. Of patients receiving lamotrigine for more than 6 months, half received an average dose of 200–400 mg/day. Results: Lamotrigine was well tolerated, with an adverse-event profile generally comparable to placebo. The most common adverse event was headache. Lamotrigine did not destabilize mood and was not associated with sexual adverse effects, weight gain, or withdrawal symptoms. Serious rash was very rare in the lamotrigine group (0.1%).
