title: Lamotrigine and severe skin eruptions.
abstract: Lamotrigine is an important new addition to the drugs used to treat people with seizure disorders, but disconcerting are reports of a higher than expected incidence of severe skin reaction among children. Using automated data from three HMOs, we conducted a retrospective investigation of children (<15 years) exposed to lamotrigine from 1 January 1995 to 30 June 1997. The outcome of interest was hospitalization for a severe skin reaction (e.g. erythema multiforme). Lamotrigine was dispensed to 124 children (56% female, mean age 8.7 years); the mean number of dispensings per person was 10. Of those exposed, 59 (47%) were hospitalized at least once during the study period, mainly for convulsions and epilepsy. There were no hospitalizations for or with a diagnosis of severe skin reactions. Our investigation revealed no evidence to support a causal relationship between lamotrigine and severe skin reactions. However, because our sample size was small we had power to detect only a very strong association between lamotrigine and severe skin disease. Taken alone, our study does not establish the risks of lamotrigine. These results should be viewed as a contribution to the totality of evidence that will be used to assess the safety of lamotrigine.
authors.affiliation: Channing Laboratory, Brigham and Women's Hospital, Boston, MA 02115, USA. jim.donahue@channing.harvard.edu
authors.forename: J G
authors.initials: JG
authors.lastname: Donahue
authors.forename: S E
authors.initials: SE
authors.lastname: Andrade
authors.forename: E M
authors.initials: EM
authors.lastname: Cain
authors.forename: T A
authors.initials: TA
authors.lastname: Defor
authors.forename: M J
authors.initials: MJ
authors.lastname: Goodman
authors.forename: J
authors.initials: J
authors.lastname: Gurwitz
authors.forename: R
authors.initials: R
authors.lastname: Platt