FDA issues safety warning on prenatal use of Lamictal
The U.S. Food and Drug Administration (FDA) has issued a safety warning on the drug Lamictal, which is used to treat both bipolar disorder and epilepsy. Lamictal, manufactured by GlaxoSmithKline, has shown to be affiliated with an "elevated rate" of cleft palate or lip in the developing fetus, when a pregnant woman takes the medication during the first trimester of pregnancy.
Back in August, GlaxoSmithKline was in discussions with Health Canada, voluntarily informing Canadian physicians of what appears to be an "elevated rate" of birth defects, compared to the babies of women who were not taking the drug in their first trimester. That was the first public indicator that something might be awry.
Late last week, the FDA issued this warning for women: "If you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor. Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy. Do not start or stop using Lamictal without talking to your doctor. More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal."
In a separate warning issued to physicians, made public on the FDA website, they say: "Preliminary data from the North American Antiepileptic Drug Pregnancy Registry suggest a possible association between exposure to lamotrigine monotherapy during the first trimester of pregnancy and cleft lip and/or cleft palate. The oral clefts reported were few and were not part of a syndrome that included other birth defects. Other pregnancy registries of similar size have not replicated this observation. The validity of this possible association cannot be established until further data are collected in the NAAED Pregnancy Registry, in other ongoing pregnancy registries, or through other research efforts. The clinical significance of this preliminary report is thus uncertain."
Pregnant women who have been treated with this drug during pregnancy, or for whom it remains a necessary treatment during pregnancy, may register in the NAAED Pregnancy Registry (call 1.888.233.2334). GlaxoSmithKline, the manufacturer of lamotrigine, is also administering a pregnancy registry to learn more about this possible association (call 1.800.336.2176).
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