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From the Genetics Program (Dr. Wyszynski, R.M. Alsdorf), Department of Medicine, Boston University School of Medicine, Department of Pediatrics (Dr. Holmes, M. Nambisan, T. Surve, and C.R. Smith), Harvard Medical School, and Genetics and Teratology Unit (Dr. Holmes), Pediatric Service, Massachusetts General Hospital, Boston, MA.
Address correspondence and reprint requests to Dr. D.F. Wyszynski, Boston University School of Medicine, 715 Albany St., L-320, Boston, MA 02118; e-mail: dfw{at}bu.edu
Objective: To determine the rate of occurrence of major malformations in infants whose mothers had taken the drug valproic acid (VPA) as monotherapy during the first trimester of pregnancy and had enrolled in the North American Antiepileptic Drug Pregnancy Registry.
Methods: Data were collected from pregnant women throughout the United States and Canada through telephone-based interviews. Each woman was interviewed at enrollment, at 7 months’ gestation, and postpartum. With her written permission, the medical records of each mother and her infant were obtained. The major malformations tabulated were those identified at or before 5 days of age. The prevalence of congenital malformations among offspring of monotherapy VPA-exposed women was compared with that among infants of women exposed to all other antiepileptic drugs (internal comparison group) and with that among newborns in the Active Malformations Surveillance Program at Brigham and Women’s Hospital (external comparison group).
Results: Sixteen affected cases were identified among 149 VPA-exposed women (proportion: 10.7%; 95% CI: 6.3 to 16.9%). The prevalence in the internal comparison group was 2.9% (95% CI: 2.0 to 4.1%; odds ratio: 4.0, 95% CI: 2.1 to 7.4; p < 0.001). Assuming a 1.62% prevalence in the external comparison group, the relative risk of having an affected offspring for VPA-exposed women was 7.3 (95% CI: 4.4 to 12.2; p < 0.001).
Conclusion: Maternal exposure to valproic acid during the first trimester of pregnancy significantly increased the risk of major malformations.
See also pages 938, 949, and 955
The Antiepileptic Drug Pregnancy Registry is funded by sponsorship grants in excess of $10,000 received from each of the following: Abbott Laboratories, Elan Pharmaceuticals, GlaxoSmithKline, Novartis, Ortho-McNeil, and Pfizer Pharmaceuticals. Drs. Wyszynski and Holmes have received speaker fees from GlaxoSmithKline during 2004. R.M. Alsdorf was supported by an Undergraduate Research Opportunities Program Award from Boston University.
Received June 2, 2004. Accepted in final form December 1, 2004.
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