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From Tampere School of Public Health (M. Artama and Dr. Auvinen), University of Tampere; Pediatric Research Center (Dr. Auvinen), Tampere University Hospital; and Department of Neurology (Dr. Raudaskoski, I. Isojärvi, and Dr. Isojärvi), University of Oulu, Finland.
Address correspondence and reprint requests to Miia Artama, Tampere School of Public Health, University of Tampere, FIN-33014, Finland; e-mail: miia.artama{at}uta.fi
Objective: To compare the risk for congenital malformations in offspring between women with epilepsy being treated with antiepileptic drugs (AEDs) during pregnancy and those who discontinued their antiepileptic medication before pregnancy in a population-based cohort of female patients with epilepsy.
Methods: All patients with epilepsy (n = 20,101) eligible for AED reimbursement for the first time during 1985 to 1994 were identified from the Social Insurance Institution of Finland. Information on births during 1991 to 2000 was obtained from the National Medical Birth Registry. Information on AED use during pregnancy and on pregnancy outcomes was abstracted from medical records.
Results: Congenital malformations were more common among offspring of women on antiepileptic medication (65/1,411; 4.6%) than among offspring of untreated patients (26/939; 2.8%) (p = 0.02). The risk of malformations was substantially higher in the offspring of patients using valproate as monotherapy (OR = 4.18; 95% CI: 2.31, 7.57) or valproate as polytherapy (OR = 3.54; 95% CI: 1.42, 8.11) than of untreated patients. Polytherapy without valproate was not associated with increased risk of malformations.
Conclusion: Excess risk was confined to patients using valproate during pregnancy. The risk for malformations was not elevated in offspring of mothers using carbamazepine, oxcarbazepine, or phenytoin (as monotherapy or polytherapy without valproate).
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the June 14 issue to find the title link for this article.
Supported by Novartis Pharma Finland without restriction on publication. The work of M.A. was conducted during fellowship of the Doctoral Programs of Public Health with funding from the Ministry of Education.
Received September 21, 2004. Accepted in final form March 1, 2005.
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