Paroxetine exposure may not raise birth defect risk.(News)

PRAGUE -- Despite last year's warnings from the U.S. Food and Drug Administration regarding increased risks of congenital anomalies in fetuses exposed to paroxetine, a new prospective study suggests the risks may not be increased, according to a study presented at the annual meeting of the European Society of Human Reproduction and Embryology.

"Many women opt for pregnancy termination unnecessarily because they fear the results of unintended exposure [to paroxetine] early in their pregnancy," said investigator Dr. Wolfgang Paulus, an obstetrician-gynecologist and director of the Institute of Reproductive Toxicology at the University of Ulm, Ravens-burg, Germany.

His prospective study, conducted between 1990 and 2005, included 128 women who were exposed to paroxetine in their first trimester and 655 controls who were not exposed.

He found no difference in fetal loss between the two groups (roughly 11.5% for both) or in congenital anomalies (3% in the paroxetine-exposed group vs. 4% in controls). The anomalies noted in the paroxetine group were one case of clubfeet, one large nevus, and one case of spastic torticollis.

"There were no cardiac anomalies at all," he said, noting this has been identified by the FDA as a particular concern.

The biggest difference noted between the groups was in the rate of pregnancy terminations, which was much higher in the exposed group, at 13%, compared with 3% in controls.

Asked whether this might be partly related to the exposed group's depression as opposed to their fear of paroxetine exposure, Dr. Paulus replied it could be both.