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.

Reference:

Australian Adverse Drug Reactions Bulletin Vol 22, No. 5, October 2003. Available from URL: http://www.health.gov.au/tga