A study published in the June 28, 2007 issue of the New England Journal of Medicine (NEJM)  indicates that maternal use of Paxil® during pregnancy significantly increases the risk of ompahlocele, craniosynostosis and anencephaly. This study (Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects, Alwan et. al.) suggests that the risk of these birth defects is 4.2 times greater with the use of Paxil® during pregnancy.

This study also suggests that the maternal use of Paxil® during pregnancy more than doubles the risk of a cardiac birth defect known as right ventricular outflow tract obstruction (Odds Ratio 2.5)

The Study Published in the 2006 New England Journal of Medicine
In its February 9, 2006 issue, the New England Journal of Medicine published the results of a study that enrolled 377 women whose babies were diagnosed with Persistent Pulmonary Hypertension (PPHN). The study, conducted over a 5-year period from 1998 – 2003, included 377 mothers whose newborn babies were diagnosed with Persistent Pulmonary Hypertension (PPHN). The study also included 877 matched "controls" – mothers who had given birth to babies during the same time period and at the same hospitals that were participating in the study.

The results of this study demonstrated that babies who were born to mothers who had been prescribed Selective Serotonin Reuptake Inhibitors (SSRIs) during the second half of pregnancy were at a six-times greater risk for developing Persistent Pulmonary Hypertension (PPHN) than babies born to mothers who had not been prescribed these anti-depressant drugs. According to the authors of this study:

Although our study cannot establish causality, several possible mechanisms suggest that a causal association is plausible. The lung acts as a reservoir of antidepressant drugs, and substantial accumulation of SSRIs in the lungs has been reported. Serotonin not only has vasoconstrictive properties that increase pulmonary vascular resistance, but also mitogenic and comitogenic effects on pulmonary-smooth muscle cells. Thus higher circulating levels of serotonin in the fetus and accumulation of serotonin in the fetal lung might result in the proliferation of smooth-muscle cells that is characteristic of PPHN." New England Journal of Medicine 354: 579-587 (2006) (footnotes omitted).

Canadian Retrospective Study Published in the August 2006 Archives of General Psychiatry
In its August, 2006 issue, the Archives of General Psychiatry published the results of a retrospective study conducted in Canada by Dr. Tim F. Oberlander and others at the University of British Columbia. The study reviewed health data recorded for some 120,000 live births occurring between 1998 and 2001. In doing so, the researchers compared the health records of 1,451 babies born to depressed mothers who were treated with SSRIs during pregnancy with the records of 14,234 depressed mothers who were not treated with SSRIs. Dr. Oberlander and his colleagues found that the incidence of respiratory distress was significantly greater for babies born to depressed mothers who were treated with SSRIs - (13.9%) - compared with those babies born to depressed mothers who were not treated with SSRIs – (7.8%). The data also demonstrated that gestational age and birth weight were significantly less for babies of depressed mothers treated with SSRIs.    

The Study Published in the 1996 New England Journal of Medicine

The study published in the 2006 New England Journal of Medicine was spawned by the results an earlier study that examined the relationship between the use of fluoxetine (Prozac®) during pregnancy and certain neonatal medical complications. The earlier study - published in the 1996 New England Journal of Medicine – examined the outcomes of pregnancy for 228 women who were taking fluoxetine (Prozac®). According to the data collected in this study. The study also included 254 mothers who did not take fluoxetine (Prozac®) during their pregnancies. For purposes of data analysis, the women were divided into three groups:

• mothers who only used fluoxetine (Prozac®) during the first 24 weeks of their pregnancies (the “exposed-early group”)
• mothers who used fluoxetine (Prozac®) after the first 24 weeks of their pregnancies (the “exposed-late group”)
• mothers who did not use fluoxetine (Prozac®) during their pregnancies (the “control group”)

According to the authors of this study: 

            "With the exclusion of preterm infants, the rate of admission to special-care nurseries among infants of mothers in the exposed-late group was 23.0 percent, significantly higher than among infants of mothers in the exposed-early group (9.5 percent) or the control group (6.3 percent) (P< 0.001). Poor neonatal adaptation was described in 31.5 percent of the exposed-late group, as compared with 8.9 percent of the exposed-early group." New England Journal of Medicine 335: 1010-1015 (1996).

For purposes of this study, admission to a special-care nursery was defined as admission to a Level 2 or Level 3 nursery for any length of time." The medical complications experienced by the babies studied included jitteriness, tachypnea (rapid rate of respiration), hypoglycemia (low blood sugar), hypothermia (low core temperature), poor tone, respiratory distress, weak or absent cry, or desaturation on feeding.

The results of this earlier study indicated that for babies whose mothers took fluoxetine (Prozac®) after the 24^th week of their pregnancies (i.e. the "late-exposed" group), the risk of poor neonatal adaptation was 8.7 times greater than for babies whose mothers only used fluoxetine (Prozac®) during the first 24 weeks of their pregnancies (i.e. the "early-exposed" group).

Study published in the Journal of the American Medical Association
A study published in the May 18, 2005 issue of the Journal of the American Medical Association entitled “Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors” reported data that supported the identification of a neonatal behavioral syndrome linked to a pregnant woman’s use of Selective Serotonin Reuptake Inhibitor (SSRIs) during the last trimester of pregnancy. In reporting their data, the authors examined 13 published articles that described a total of 18 cases of neonatal disorders linked to the mother’s use of Selective Serotonin Reuptake Inhibitors (SSRIs). Of those 18 cases, 7 (38.88%) involved neonatal respiratory distress.

The authors also examined 57 case reports of adverse events reported to the FDA’s Adverse Event Reporting System (AERS). The details of these reports were identified as exhibiting the case definition of neonatal withdrawal syndrome – a neonatal condition that indicates a “withdrawal or toxicity mechanism.” According to the authors, of these 57 case reports, 3 reported “respiratory distress,” 5 reported “trouble breathing” and 7 reported tachypnea (rapid respiration) - a total of 15 out of 57 or 26.32%.

If you or someone you know was taking Prozac®, Paxil®, Zoloft® or another anti-depressant and gave birth to a baby who suffered from respiratory distress or a respiratory disorder, please click HERE to find out more about your or her legal rights.

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