Australia. The Australian Adverse Drug Reactions Advisory Committee (ADRAC) reports on the analysis of 40-month data from the ongoing Australian Pregnancy Register for Women on Antiepileptic Medication. Out of a total of 403 pregnancy outcomes in women receiving antiepileptic drugs, 87% resulted in a healthy live birth and 6.5% had a foetal malformation. The rate of foetal malformation was significantly greater for first trimester valproic acid exposure (16%) than for exposure to all other antiepileptic drugs (2.4%). In addition, the mean daily dose of valproic acid was greater in those with foetal malformations than in those without (1975 mg vs 1128 mg). The Committee points out that a recently published Finnish study also showed an association between in utero valproic acid exposure, as well as carbamazepine and oxcarbazepine exposure, and foetal malformation. The Committee says that, in pre-pregnancy planning for women taking antiepileptic drugs, prescribers should review medication with the aim of maximising seizure control while minimising the risk of foetal malformation.
Australian Adverse Drug Reactions Bulletin Vol 22, No. 5, October 2003. Available from URL: http://www.health.gov.au/tga