Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Paxil Linked to Birth Defects

Posted in Paxil Birth Defects, SSRI Birth Defects

In 2007, medical researchers J. Alexander Cole et al. published a report on the increased likelihood of congenital malformations in infants whose mothers used Paxil® (paroxetine) during pregnancy and found some startling results.

This study, titled “Paroxetine in the first trimester and the prevalence of congenital malformations,” published in the journal Pharmacoepidemiology and Drug Safety, tracked 1835 children born to 1780 mothers who used Paxil® during pregnancy, and compared the health of those children to 4198 children born to 4072 mothers who used other antidepressants during pregnancy.[1]

Results showed that Paxil use during pregnancy increased the risk for birth defects by a factor of nearly 90%.[2]  For heart malformations specifically, use of Paxil® raised the risk of these birth defects by about 46%.[3]

When researchers controlled for time of Paxil® use during pregnancy, it was found that if a mother used Paxil® during the first trimester, her child is more than twice as likely to be born with birth defects.[4]  The authors of this paper also cite research that has shown Paxil® use may place children at a four-fold increased risk for birth defects.[5]

Heart defects found to be associated with Paxil® use included aortic stenosis, atrial septal defects, patent ductus arteriosus, ventricular septal defects, and pulmonary stenosis.[6]  These birth defects are serious malformations of the heart that often require surgery, and may be fatal.

Though this article does not include biochemical information describing how Paxil® causes these birth defects, it goes great length to demonstrate that Paxil® causes birth defects.  Because warning labels on Paxil® did not include any information about the increased risk for birth defects until 2005 when a limited new warning was placed on the Paxil® label as required by the FDA, a number of Paxil birth defects lawsuits are currently being filed.

If you used Paxil® during pregnancy and your child was born with a congenital malformation, please do not hesitate to contact our team of Paxil birth defects lawyers at the information provided below.  We have the skills, resources, and experience required to go up against even the largest of pharmaceutical companies and secure the compensation you and your family deserve.

At your convenience, you may reach us by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.  We are here to help you and yours every step of the way.

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.


[1] Cole, J.A. et al. (2007) “Paroxetine in the first trimester and the prevalence of congenital malformations” Pharmacoepidemiology and Drug Safety Vol. 16; pp. 1075-1085.

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.