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From GlaxoSmithKline, Worldwide Epidemiology, Harlow, UK.
Address correspondence and reprint requests to Dr. M. Cunnington, GlaxoSmithKline, Worldwide Epidemiology, Harlow, UK; e-mail: Marianne.C.Cunnington{at}gsk.com
Objective: To report the frequency of major malformations in lamotrigine-exposed pregnancies from September 1, 1992, through March 31, 2004, in the International Lamotrigine Pregnancy Registry.
Methods: Health care professionals throughout the world can voluntarily enroll lamotrigine-exposed pregnancies in this observational study. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The percentage of outcomes with major birth defects was calculated as the total number of outcomes with major birth defects divided by the sum of the number of outcomes with major birth defects + the number of live births without defects.
Results: Among 414 first-trimester exposures to lamotrigine monotherapy, 12 outcomes with major birth defects were reported (2.9%, 95% CI 1.6% to 5.1%). Among the 88 first-trimester exposures to lamotrigine polytherapy including valproate, 11 outcomes with major birth defects were reported (12.5%; 95% CI 6.7% to 21.7%). Among 182 first-trimester exposures to lamotrigine polytherapy excluding valproate, 5 outcomes with major birth defects were reported (2.7%, 95% CI 1.0% to 6.6%). No distinctive pattern of major birth defects was apparent among the offspring exposed to lamotrigine monotherapy or polytherapy.
Conclusions: The risk of all major birth defects after first-trimester exposure to lamotrigine monotherapy (2.9%) was similar to that in the general population and in other registries enrolling women exposed to antiepileptic monotherapy (3.3% to 4.5%). However, the sample size was too small to detect any but very large increases in specific birth defects.
See also pages 938, 949, and 961
*Members of the International Lamotrigine Pregnancy Registry Scientific Advisory Committee are listed in the Appendix.
The International Lamotrigine Pregnancy Registry was established by Burroughs Wellcome (now GlaxoSmithKline [GSK]) in 1992. The Registry methodology was developed in conjunction with a scientific advisory committee, the majority of whom are independent of the sponsor (two GSK representatives and four independent members). These individuals (see the Appendix) receive no payment for the time they contribute toward the Registry. The Registry is managed by, and the data are analyzed by, the Contract Research Organization, Inveresk. Data are reviewed, and conclusions developed, on a 6-month basis by the scientific advisory committee. The article was reviewed and approved by the scientific advisory committee. M.C. is an epidemiologist currently employed by GSK. P.T. was employed by GSK until November 2002, and has since worked for the Research Triangle Institute.
Received April 21, 2004. Accepted in final form October 6, 2004.
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