Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with
epilepsy, and other approved indications including bipolar disorder, may require or be
unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are
few data available on drug safety in pregnancy: data from animal models may not translate
directly to humans and pregnant women are routinely excluded from clinical trials. The
International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992
to monitor the safety of lamotrigine during pregnancy.