In 2006, a research study by Bérard et al., a Canadian research team, titled “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage” was published in Birth Defects Research (Part B) that made several important conclusions about the safety of Paxil® use during pregnancy.

In 1,403 infant-mother pairs studied in this research (all mothers used antidepressants during pregnancy) over 100 major birth defects were found.[1]  And while this constitutes a dramatic increase in the incidence of major birth defects – the rate for major birth defects in the general population is about 2%[2] – these findings did not conclude that SSRI (selective serotonin reuptake inhibitor) use raised the risk for birth defects compared to other antidepressants, broadly.

When dosage and timing of drug use were studied in particular, it was found that maternal SSRI use is far more risky for a developing child.  Children born to mothers who used more than 25mg of Paxil® (paroxetine) daily during the first trimester were more than twice as likely to be born with a major congenital malformation as were children born to mothers who used other antidepressants during pregnancy.  And, children born to mothers who used 25mg of Paxil® per day during the first trimester were more than three times as likely to be born with a major heart malformation as were children born to mothers who used other antidepressant medications during pregnancy.

Though the Bérard et al. study does not show how SSRIs cause birth defects, along with physician consultation, these findings may help guide one’s pharmaceutical choices during pregnancy.  If there is something that can be done to avoid excess risk for major birth defects without causing harm, it should be done.  Pregnant mothers should have the information required to make informed, quality decisions pertaining to the health of their child.

Regrettably, the manufacturers of Paxil® have not included adequate warnings regarding the increased risk for birth defects their product creates.  Because of this failure, many Paxil® birth defect lawsuits are currently being filed, seeking compensation for injury sustained to children placed at risk for birth defects through no fault of their mothers.  If you used Paxil® during pregnancy and your child was born with a congenital malformation, you may be entitled to financial compensation.  Please do not hesitate to contact our team of Paxil® birth defect lawyers for a free, no-obligation consultation at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the compassion, experience, and resources required to help your family every step of the way.


[1] Bérard, A., et al. (2006) “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage” Birth Defects Research (Part B) Vol. 80; pp. 18-27

[2] “Birth Defect Risks: Factors and Considerations” Baby Zone © Disney BabyZone.com Available at <http://www.babyzone.com/pregnancy/fetal-development/birth-defects-risks_70721> Accessed 15 February 2013