A recent study by Carol Louik, et al. published in the New England Journal of Medicine has evaluated the risk of birth defects among infants born to mothers who used a type of antidepressant medication called selective-serotonin reuptake inhibitors (SSRIs) during pregnancy, as compared to the risk among infants whose mothers did not use such drugs during pregnancy.  Some of the results the Louik team found were shocking.

Infants whose mothers used the drug sertraline (Zoloft®) during the first trimester of pregnancy were found to be 5.7 times more likely to be born with omphalocele,[1] a disease defined by the National Institutes of Health as “a birth defect in which the infant’s intestine or other abdominal organs stick out of the belly button (navel).  In babies with an omphalocele, the intestines are covered only by a thin layer of tissue and can be easily seen.”[2]

While this disease is usually corrected with surgery,[3] it may result in “death of the intestinal tissue”[4] or “intestinal infection”[5] – both of which are very serious ailments for a newborn.

The Louik study also found that infants whose mothers used Zoloft® in the first trimester were twice as likely as other infants to be born with septal defects,[6] a type of heart malformation in which one of holes that normally exists between the chambers of the heart before birth does not close at birth.[7]  There are two different kinds of septal defects – atrial septal defects and ventricular septal defects.  If the hole between the atria (the two upper chambers of the heart) does not close at birth, the condition is termed an atrial septal defect (ASD).  If the hole between the right and left ventricals of the heart does not close by birth, the resulting condition is termed a ventrical septal defect (VSD).

Depending on the size of the septal defect, it may close on its own shortly after birth without complication.  If the septal defect is larger, however, the newborn infant may require heart surgery to close the opening and ensure normal heart functioning.

MedlinePlus, a medical encyclopedia provided by the National Library of Medicine and the National Institutes of Health, cautions:

“People with a larger or more complicated ASD are at an increased risk for developing a number of problems, including:

  • Arrhythmias, particularly atrial fibrillation
  • Heart failure
  • Heart infections (endocarditis)
  • High blood pressure in the arteries of the lungs (pulmonary hypertension)
  • Stroke”[8]

Because the Louik article so clearly illustrates the undue risks that SSRI drugs such as Zoloft® present to unborn children, this article could help provide convincing evidence of the dangers of Zoloft® in a Zoloft® lawsuit.

If you were prescribed Zoloft® during pregnancy and your child was born with omphalocele or a septal defect, please do not hesitate to contact our law firm for a free consultation.  We are here to help.


[1] Louik, C. et al. (2007) “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects” The New England Journal of Medicine Vol. 356, No. 26. p. 2675-2683

[2] “Omphalocele – PubMed Health” U.S. National Library of Medicine © 2011 A.D.A.M. Medical Encyclopedia  available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001989/> accessed 10 January 2013

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Louik, C. et al. (2007) “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects” The New England Journal of Medicine Vol. 356, No. 26. p. 2675-2683

[7] “Atrial septal defect (ASD): MedlinePlus Medical Encyclopedia” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. © 1997-2013 A.D.A.M. Medical Enclopedia available at <http://www.nlm.nih.gov/medlineplus/ency/article/000157.htm> accessed 10 January 2013

[8] Ibid