Zoloft Pregnancy Risk Has Been Known to Pfizer

Harvey Kirk

By Harvey Kirk
Posted February 3, 2012


The lawyers at Saiontz & Kirk, P.A. represent children throughout the United States who are pursuing compensation through a Zoloft lawsuit for birth defects and malformations caused by exposure to the medication while their mother was pregnant. Although Pfizer, the manufacturer of the popular antidepressant, has known or should have known about the Zoloft pregnancy risks for years, they marketed the medication with inadequate warnings for consumers and the medical community.

Zoloft (sertraline) was introduced in December 1991. It is part of a class of medications known as SSRI (selective serotonin reuptake inhibitor), and side effects of Zoloft have been shown to increase the risk of infants being born with serious defects and malformations, such as heart defects, neural tube defects, abdominal defects, cleft palate, cleft lip, club foot, spina bifida and persistent pulmonary hypertension in newborns (PPHN).

Before the drug was even approved by the FDA, Pfizer knew that Zoloft pregnancy use caused birth defects in non-mammalian species. Even if the malformations were not established among humans at that time, it was clear that Zoloft crossed the placenta, and Pfizer had a duty to fully research the pregnancy risks with Zoloft before promoting it heavily to millions of Americans.

Zoloft has grown to become one of the most widely prescribed medications in the United States, while the drug maker has ignored information about the risks of use while pregnant and failed to provide adequate warnings about birth defects from Zoloft. Evidence of pregnancy and birth problems has been building over the years since the drug was introduced, and thousands of children have been forced to serve as unwilling human test subjects.

Medical literature published over the past two decades provides a good outline to establish that Pfizer has intentionally turned a blind eye and allowed women to become pregnant while taking Zoloft as a result of their decision to place profits before patients safety:

1996: A study published in the New England Journal of Medicine suggests that SSRI medications like Zoloft increase the risk of prematurity, poor neonatal adaption, low birth weight and PPHN when taken late in pregnancy.

2002: A study in the American Journal of Psychiatry warns that SSRI use during pregnancy can cause low gestational age and birth weight, longer hospital stays and low APGAR scores.

2006: A New England Journal of Medicine study finds that side effects of Zoloft and other SSRI may increase the risk of PPHN when taken by pregnant women after the 20th week.

2006: A study in the Archives of General Psychiatry provided further support for the findings of the 2002 American Journal of Psychiatry study about the pregnancy risks of Zoloft and other SSRI medications.

2007: Another New England Journal of Medicine study finds that pregnant women who take Zoloft and other SSRI medications faced an increased risk of cranial birth defects, as well as omphalocele, where internal organs may develop outside of the infant’s body. Another study in the same journal that year links Zoloft use to an increased risk of septal heart defects.

2009: A study known as the Pederson Study was published by the British Medical Journal, which found that pregnancy use of Zoloft and Celexa specifically were associated with an increased prevalence of septal heart defects. The study also found that using more than one type of SSRI during the first trimester quadrupled the risk of heart birth defects.

2010: The Kornum Study, published in the journal Clinical Epidemiology, found that most SSRIs increase the risk of cardiac malformations, but none as much as Zoloft when taken during pregnancy.

Based on the information available to Pfizer, Zoloft should be classified as a Category D pregnancy drug, indicating that there is positive evidence of human fetal risk. However, women and doctors continue to be provided with vague and confusing information about the extent of the risk children face from pregnancy use of Zoloft.


The Zoloft birth defect lawyers at Saiontz & Kirk, P.A. review potential claims for children throughout the United States who have been born with serious and devastating health problems that were caused by the use of Zoloft during pregnancy. Financial compensation may be available through a Zoloft lawsuit for the life-time of medical bills and disability children born with these birth defects and malformations must face.

All claims are reviewed under a contingency fee agreement, which means that there are no out-of-pocket expenses to review a potential claim with our law firm and there are never any attorney fees unless a recovery is obtained. To review a case for your child or a family member, request a free consultation and claim evaluation.

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