Epilepsy drug may be linked to birth defect

Lamictal epilepsy drug during the first three months of pregnancy may increase the chances of having a baby with a cleft lip or palate, U.S. regulators warned on Friday.

“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,” the Food and Drug Administration said in an alert posted on its Web site.

Women who are pregnant or thinking of becoming pregnant should not stop taking Lamictal without talking to a doctor, the FDA said. The drug’s generic name is lamotrigine.

“Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy,” the FDA said.

After discussions with Health Canada in August, Glaxo said the cleft palate deformity was detected at “an elevated rate” in infants whose mothers took the drug during the first three months of pregnancy, compared with others who were not exposed to the drug.

A spokesman for Glaxo in London said the safety and efficacy profile of Lamictal was well established but, as with all medicines, doctors had to make decisions about prescribing based on the risk/benefit profile of individual patients.

“We have been in discussions with FDA for several months on this matter. It is clear that more data is required, as the FDA have said in their advisory,” he added.

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Lamictal sales totalled $1.59 billion worldwide last year, with $1 billion generated in the U.S.

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Earlier this week the drug was approved by the FDA to treat one of the most serious forms of epilepsy, known as “grand mal” seizures, in children aged 2 and older as well as for adults.

Lamictal is already approved as an additional therapy to treat partial seizures and seizures associated with Lennox-Gastaut syndrome. It is also approved as a maintenance therapy for adults with bipolar disorder, or manic depression.

Taking GlaxoSmithKline Plc’s  Lamictal epilepsy drug during the first three months of pregnancy may increase the chances of having a baby with a cleft lip or palate, U.S. regulators warned Friday.

“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,” the Food and Drug Administration said in an alert posted on its Web site.