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Paroxetine, fluoxetine use prior to conception may increase risk for birth defects

Results from a multicenter, population-based, case-control study show that children of mothers who used paroxetine and fluoxetine were 2 to 3.5 times more likely to have birth defects, while other selective serotonin reuptake inhibitors used periconceptionally were not associated with birth defects.

“[Selective serotonin reuptake inhibitors] are increasingly used by women of reproductive age and during pregnancy, but the inconsistent reports have limited opportunities for clinicians to carefully evaluate the risk compared with benefit of specific [selective serotonin reuptake inhibitors] for a given patient during pregnancy,” study researcher Jennita Reefhuis, PhD, of the CDC’s National Center for Birth Defects and Developmental Disabilities, and colleagues wrote in BMJ.

Researchers analyzed data from the National Birth Defects Prevention Study for 17,952 mothers of infants with birth defects and 9,857 mothers of infants without birth defects with estimated delivery dates between 1997 and 2009. The final study cohort included 17,293 children with birth defects unexposed to selective serotonin reuptake inhibitors (SSRIs), 659 children with birth defects exposed to citalopram, escitalopram, fluoxetine, paroxetine or sertraline, 9,559 children with no birth defects unexposed to SSRIs and 298 children with no birth defects exposed to one SSRI.

Sertraline was the most commonly used SSRI, according to researchers.

Analysis indicated no association between birth defects and maternal use of citalopram or escitalopram monotherapy, except for a marginal association between citalopram and neural tube defects.

Exposure to fluoxetine was associated with ventricular septal defects, right ventricular outflow tract obstruction cardiac defects and craniosynostosis.

Paroxetine exposure was significantly associated with five of the seven defects assessed. Further, analysis confirmed associations between paroxetine and anencephaly, atrial septal defects, right ventricular outflow tract obstruction cardiac defects, gastroschisis and omphalocele found in previous studies, according to researchers.

Exposure to sertraline was not significantly associated with any of the five birth defects explored in the study.

“This analysis confirms the need to assess the association between specific SSRIs and specific birth defects rather than combining an entire drug class or heterogeneous group of birth defects. Although SSRIs are similar pharmacologically, there are chemical differences, and if any of them do have teratogenic activity, it may be completely unrelated to the inhibition of serotonin receptors,” Reefhuis and colleagues concluded. – by Amanda Oldt

Disclosure: The researchers report no relevant financial disclosures.