Increased rate of major malformations in offspring exposed to valproate during pregnancy.
نویسندگان
چکیده
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.
منابع مشابه
Valproate and the risk for congenital malformations: Is formulation and dosage regime important?
BACKGROUND Use of valproate in pregnancy, especially in doses over 1000mg a day, is known to be associated with a higher risk for major congenital malformations compared with other antiepileptic drugs. We sought to investigate whether the increased risk could be minimised by using controlled release or divided daily doses of valproate. METHODS The UK Epilepsy and Pregnancy Register is a prosp...
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PURPOSE To quantify the risks of intrauterine antiepileptic drug (AED) exposure in monotherapy and polytherapy. METHODS Data from five prospective European studies totaling 1,379 children were pooled and reanalyzed. Data were available for 1,221 children exposed to AED during pregnancy and for 158 children of unexposed control pregnancies. RESULTS Overall, when comparing a subgroup of 192 c...
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The practice of medicine is rooted in secure statistical support, derived from carefully constructed studies, to provide the knowledge base on which clinical decisions rest. In such a well formed culture, weak disease associations or observations in small groups of patients not reaching statistical significance, whilst discomfiting, are often sidelined pending further evidence. Worse, they may ...
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ورودعنوان ژورنال:
- Neurology
دوره 64 6 شماره
صفحات -
تاریخ انتشار 2005