U.S. says Glaxo drug may be linked to birth defect

WASHINGTON (Reuters) - 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 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 at http://www.fda.gov/cder/drug/infopage/lamotrigine/default.htm.

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.

A GlaxoSmithKline spokeswoman could not immediately be reached for comment.

After discussions with Health Canada in August, GlaxoSmithKline 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.