Paroxetine and Birth Defects: The FDA Issues an Advisory

In response to the findings of two as-yet-unpublished trials, the FDA has issued a public health advisory on the risk for birth defects with the use of the selective serotonin reuptake inhibitor (SSRI) paroxetine (available most commonly as Paxil).1 Previous epidemiologic studies have suggested a possible association between paroxetine use and omphalocele and craniosynostosis; other studies found a small risk for congenital anomalies and congenital heart malformations or no effect. The new studies suggest that prenatal maternal exposure to paroxetine increases the risk for congenital malformations, especially cardiovascular malformations.

One of the unpublished studies, based on U.S. epidemiologic data, showed a 1.5-fold increase in risk for…