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Anti-Epileptic Drug Exposure During Pregnancy Increases Risk of Major Congenital Malformations: Presented at ECE By Thomas S. May RHODES, Greece -- June 29, 2010 -- Two major studies presented here on June 28 during a platform session on drug therapy at the 9th European Congress on Epileptology (ECE) have found that several anti-epileptic drugs (AEDs) are associated with major congenital malformations (MCMs) in the offspring of women taking AEDs during pregnancy. One of the studies, EURAP (an international registry of antiepileptic drugs and pregnancy), assessed the comparative risk of major MCMs following exposure to AEDs during pregnancy. The researchers looked at pregnancy outcomes in over 5,000 pregnancies involving AEDs and recorded the number of MCMs at 12 months after birth. Out of 5,707 pregnancies, 39 ended in induced abortions due to fetal abnormalities, 43 in perinatal deaths, 88 in stillbirths, and 5,537 in live births. The rate of MCMs associated with lamotrigine was 2.9%, carbamazepine 5.7%, valproate 9.3%, phenobarbital 7.5%, while other monotherapies resulted in a combined rate of 3.4%. Compared with lamotrigine monotherapy, the risks of MCMs were significantly higher with valproate (odds ratio [OR], 3.4), phenobarbital (OR, 2.7), and carbamazepine (OR, 2.1). Similar results were also obtained in the other study, which was based on data from the UK Epilepsy and Pregnancy Register. In the prospective, observational study, researchers analysed a total of 6,225 cases and found that the risk of MCM was significantly higher in women who were on AEDs during pregnancy (n = 5,475), compared with those who received no AEDs (n = 445; relative risk [RR], 1.74). In addition, AED polytherapy (n = 1,199) resulted in significantly higher rates of MCM than monotherapy (n = 4,276; RR, 1.72). On the basis of these results, the researchers concluded that AED exposure during pregnancy increases the risk of MCM in the babies of women with epilepsy, and they also noted that polytherapy exposure is associated with a higher risk than monotherapy. According to session co-chair James Morrow, MD, Royal Victoria Hospital, Belfast, United Kingdom, physicians need to be aware of these findings, so they can properly advise women with epilepsy who are contemplating pregnancy. "Awareness of the increased risks -- particularly associated with valproate -- in pregnancy is very important," he said. Funding for this study was provided by the Epilepsy Research Foundation, Eisai, GlaxoSmithKline, Janssen-Cilag, Novartis, Pfizer, sanofi-aventis, and UCB Pharma. [Presentation title: Malformation Risks After Monotherapy Exposure to Antiepileptic Drugs: First Report From EURAP. Abstract 253 AND Malformation Risks of Antiepileptic Drugs (AEDs) in Pregnancy: An Update From the UK Epilepsy and Pregnancy Register. Abstract 274] E-mail this page to a friend or colleague! To print, use this version