Women with epilepsy who need to take an antiepileptic drug during pregnancy are always concerned -- as are their doctors -- to find the safest drug for their unborn child while ensuring seizure control. Recently the FDA issued an alert concerning Lamictal. The Agency noted that women taking the drug during the first three months of pregnancy have a higher chance of giving birth to a child with a cleft lip or cleft palate.

Unfortunately, there is no medication that has been proven safe for the developing fetus. Older and more extensively used newer medications have been studied and most are associated with small but increased risks of major congenital malformations. The risk can probably be reduced by using a single drug at low to moderate doses and avoiding high peak levels. But we do not have a way to eliminate the risk.

What about the newer drugs for whom pregnancy registry data are not available? We simply do not know the answer. Some may be safe; others may be more dangerous. There is an old saying in medicine: new drugs have benefits and old drugs have side effects. This saying is a caricature of how medical knowledge progresses. Initially there may be a focus on effectiveness; however, with greater experience, additional side effects are discovered. Truth be told, it is only through experience that we learn about both the efficacy and safety of medications.

Editor’s note: Further information about antiepileptic drugs during pregnancy is available through the following links:

• www.fda.gov/cder/drug/InfoSheets/patient/lamotriginePIS.pdf -- FDA Patient Information Sheet for Lamotrigine (marketed as Lamictal™)
• www.epilepsy.com/articles/ar_1159293884.html -- FDA Approves New Epilepsy Indication for Lamictal™
• professionals.epilepsy.com/page/hallway_valproate_pregnancy.html--Valproate May Increase Adverse Pregnancy Outcomes. (This new feature, with comments from epilepsy experts, talks about several antiepileptic drugs including Lamotrigine.)
• www.epilepsy.com/articles/ar_1157461548.html -- New Study Reveals Link Between Valproate and Birth Defects (an interview with Kimford Meador, MD, lead author of the study).