A NORTH-AMERICAN REGISTRY FOR EPILEPSY AND PREGNANCY, A UNIQUE PUBLICPRIVATE PARTNERSHIP OF HEALTH SURVEILLANCE/

Purpose: A North American Registry of Epilepsy and Pregnancy (NAREP) h as been established as a surveillance mechanism to identify adverse pr egnancy outcomes that may be associated with fetal exposure to antiepi leptic drugs (AEDs). As public attitudes become more receptive, and me dical management more effective, women with epilepsy (WWE), are choosi ng to become pregnant in increasingly larger numbers. In the United St ates alone, 800,000 to 1.1 million WWE are of childbearing age. The of fspring of these women have rates of congenital malformations of 1.25- 11.5%. Although several factors could contribute to this risk, includi ng AEDs, seizures during gestation, and maternal epilepsy, AEDs are an important variable over which we have some control. Unfortunately, no data currently exist that permit physicians to determine the relative safety of specific AEDs. With the introduction of several new AEDs, t here is even further uncertainty about the potential safety of AEDs fo r treatment of pregnant women. Methods: We have organized a prospectiv e registry for pregnant WWE which will systematically monitor pregnanc y outcomes. The registry can serve as an early warning system for adve rse outcomes associated with specific AEDs, administered alone or in c ombination. The registry has required a cooperative effort between the scientific and pharmaceutical communities. The genesis of this effort is described.