Safety of the newer antiepileptic drug oxcarbazepine during pregnancy.

OBJECTIVE Seizure control in pregnant women with epilepsy is vital, as maternal seizures may have deleterious consequences. The treatment of pregnant women with epilepsy is, however, complicated by the teratogenicity of older antiepileptic drugs (AEDs). In this review, the safety of the newer AED oxcarbazepine during pregnancy is assessed based on published pregnancy outcome data. Other relevant safety issues, such as oxcarbazepine pharmacokinetics during pregnancy and the compatibility of oxcarbazepine treatment with breastfeeding, are also discussed. METHODS Literature searches of the following databases were performed: MEDLINE, EMBASE, eNova, NOWIMA (an internal Novartis Germany database), Derwent Drug File, SciSearch and BIOSIS. Identified publications were examined for original data reporting rates of foetal malformation following maternal exposure to oxcarbazepine as monotherapy or adjunctive therapy. RESULTS Relevant publications reporting data from the worldwide Novartis safety database and pregnancy registries or study centres in six countries were identified. A total of 248 pregnancies involving maternal exposure to oxcarbazepine monotherapy and 61 involving adjunctive therapy were reported. There were six malformations among the monotherapy group, equating to a malformation rate of 2.4% (6/248). The malformation rate reported in the general population is 2-4%. There were four malformations associated with oxcarbazepine adjunctive therapy, equating to a malformation rate of 6.6% (4/61). CONCLUSIONS This literature review suggests that, compared with newborns in the general population, the newborns of women receiving oxcarbazepine monotherapy during pregnancy do not appear to show an increased risk for malformations. However, the number of pregnancies involving maternal exposure to oxcarbazepine identified by this review is not sufficient to draw definitive conclusions. Additional information from large-scale pregnancy registries is required to confirm the safety profile of oxcarbazepine as monotherapy or adjunctive therapy during pregnancy.