PURPOSE: A North American Registry of Epilepsy and Pregnancy (NAREP) has been established as a surveillance mechanism to identify adverse pregnancy outcomes that may be associated with fetal exposure to antiepileptic drugs (AEDs). As public attitudes become more receptive, and medical management more effective, women with epilepsy (WWE), are choosing to become pregnant in increasingly larger numbers. In the United States alone, 800,000 to 1.1 million WWE are of childbearing age. The offspring of these women have rates of congenital malformations of 1.25-11.5%. Although several factors could contribute to this risk, including 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, there is even further uncertainty about the potential safety of AEDs for treatment of pregnant women.
METHODS: We have organized a prospective registry for pregnant WWE which will systematically monitor pregnancy outcomes. The registry can serve as an early warning system for adverse outcomes associated with specific AEDs, administered alone or in combination. The registry has required a cooperative effort between the scientific and pharmaceutical communities. The genesis of this effort is described.
