Abstract
Abstract: To estimate the risk of congenital malformation with antiepileptic drugs exposure during pregnancy reported to the UK National Teratology Information Service (NTIS). Only limited local guidelines are available to clinicians as to which drugs are most appropriate for women of childbearing age. Using standardised procedures, NTIS, has provided prospective fetal risk assessment and collected outcome data in 184 women (115 monotherapy, 69 polytherapy) taking antiepileptic drugs (AEDs) throughout pregnancy. The results are in both groups, the majority of live born babies were normal (91.8% monotherapy, 85.7% polytherapy). The incidence of malformations was higher than expected; (8.1% monotherapy, 14.3% polytherapy vs 2-3% expected). The incidence of miscarriage (12.1% and 1.4% vs 10-20%) and elective terminations (14.7% and 8% vs 23%) was within the expected range. The wide range of congenital malformations was observed including cardiac malformations and facial clefts. There were no neural tube defects (NTDs) in either group. The majority of live born babies in these high risk groups were normal. The incidence of malformations in women treated with old and newer AEDs was higher than expected, with a higher incidence observed in the polytherapy group. A range of malformations was reported, but no NTDs were observed following valproate and carbamazepine exposures.