Rash in adult patients receiving lamotrigine to treat bipolar I disorder in Korea: a multicenter, prospective, naturalistic, open-label trial.

The goal of this study was to assess the incidence of rash occurring in patients received lamotrigine to treat bipolar I disorder in a real world setting in Korea. We included a heterogeneous sample with multiple medications and medical comorbidities. Lamotrigine was added to the current therapy regime for DSM-IV bipolar I patients on an open-label basis for 12 weeks. The incidences of rash and other adverse events were assessed. The primary outcome measure was the incidence of rash. A total of 237 adult patients were included in the present study and 173 patients (73.0%) completed the 12 weeks of treatment. Thirty patients (12.7%) developed a rash, of whom 2 (0.8%) developed a serious rash. There were no patients who developed Stevens-Johnson syndrome or toxic epidermal necrolysis. The median time of rash onset was 16 days. As a group, patients who did not experience rash were significantly heavier than those who did. Our findings suggest that the incidence of serious rash associated with lamotrigine is low. The prescription of lamotrigine should be undertaken with appropriate consideration of the potential risk of adverse events including rash to the patient in relation to potential benefit from improvement of bipolar disorder.