Journal article

The teratogenic risk of antiepileptic drug polytherapy

Frank JE Vajda, Alison A Hitchcock, Janet Graham, Terence J O'Brien, Cecilie M Lander, Mervyn J Eadie



PURPOSE: To compare the risks of fetal malformation during pregnancy associated with antiepileptic drug (AED) polytherapy and monotherapy. METHODS: Statistical analysis of malformation rate and antiepileptic drug exposure data from the Australian Register of Antiepileptic Drugs in Pregnancy, and from the literature. RESULTS: The calculated relative risk (RR) value for AED polytherapy compared with monotherapy was below 1.0 in only 3 of 14 literature publications. In the register, at 1 year postnatally there were fetal malformations in 5.32% of 282 AED polytherapy pregnancies, and in 7.84% of 791 AED monotherapy pregnancies, an RR of 0.68 [95% confidence interval (CI) 0.39-1.17). For pregnanc..

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Funding Acknowledgements

We wish to acknowledge the support of our colleagues, medical and nonmedical, for referring patients and increasing patient awareness of the register. We thank the Scientific Advisory Board and the Ethical Research Committees of St Vincent's Hoptal, Monash Medical Centre and the Royal Melbourne Hospital, and other institutions. We are indebted for support from the Epilepsy Society of Australia, The Victorian Epilepsy Foundation, Epilepsy Australia, and generous financial support from the pharmaceutical industry, including Sanofi-Synthelabo, UCB Pharma, Janssen Cilag, Novartis, and Pfizer, as well as past support from Glaxo.Disclosure: None of the authors has any conflict of interest to disclose.