Paxil and Birth Defects

The antidepressant Paxil has been linked to possible birth defects when women take the drug in their first three months of pregnancy. A joint study conducted by the FDA and the maker of Paxil reviewed medical records of infants born to women who took Paxil. They compared them to women who took other antidepressants during the first three months of pregnancy. Women who take Paxil may be more likely to have a baby born with an abnormality.

Exposure to Paxil in the first trimester of pregnancy may increase the risk at birth for "congenital malformations", physical defects present at birth that can involve the brain, heart, lungs, liver, bones, or intestinal tract. Congenital malformations are currently the leading cause of infant deaths in the U.S.; some examples include heart defects, cleft lip, cleft palate, Down syndrome, spina bifida, or limb defects.

Even with this warning, "women currently taking Paxil should not discontinue treatment without talking to a doctor first," says the FDA. It then goes on to say that Paxil and its generic version, paroxetine, "should usually not be taken during pregnancy."

Paxil has been in the news before. There have been complaints of severe withdrawal symptoms, risks of suicidal behavior and increased violence in children and adolescents. GlaxoSmith Kline, the manufacturer of Paxil, says it is waiting for final results of the studies to "better understand the birth defect risk."

Study Details
A joint study conducted by the FDA and the maker of Paxil reviewed medical records of 3,581 infants born to women who took Paxil or other antidepressants during the first trimester of pregnancy. A preliminary analysis found infants born to women who took Paxil were more likely to be born with an abnormality than babies born to women who took another antidepressant.