FDA NOTES POSSIBLE RISK FOR PREGNANT WOMEN TAKING LAMICTAL

The FDA said Sept. 29 that babies exposed during the first three months of pregnancy to the drug Lamictal, which is used to treat epileptic seizures and bipolar disorder, may have a higher chance of being born with a cleft lip or cleft palate.

The agency issued separate advisories to healthcare professionals and patients, suggesting that, although more research is needed, women who are pregnant and taking or thinking about taking Lamictal (lamotrigine) should not start or stop without first talking to their physicians. The "new preliminary information" comes from the North American Antiepileptic Drug Pregnancy Registry.

However, the FDA cautioned that few oral clefts were in fact reported and that they "were not part of a syndrome that included other birth defects." The agency also stated that, "Pregnant women and unborn children may face significant health risks from untreated epilepsy or bipolar disorder."

Other pregnancy registries of similar size have not detected an increased risk of cleft lip or cleft palate in babies whose mothers are taking Lamictal. The manufacturer, GlaxoSmithKline, has set up its own pregnancy registry to study this effect, the FDA said.