Zoloft Birth Defects

Setraline, commonly known by its brand name Zoloft, is an antidepressant medication prescribed for depression, panic disorders, social anxiety, and more. Zoloft was once prescribed to pregnant women under the assumption that there was no known health risks to infants. However, recent research confirms that a host of birth injuries and defects can occur after taking several forms of antidepressant medications, including Zoloft.

Risks Associated with Zoloft for Mothers

In 1991, pharmaceutical company Pfizer introduced Zoloft, and it quickly became one of the most prescribed drugs for depression. Zoloft has been given a grade of ‘C” by the U.S. Food and Drug Administration (FDA). Medications with a classification of “C” have been shown to cause harm when tested on animals. Yet, pregnant women were prescribed Zoloft regardless. Since testing is not performed on infants, there was no way to officially prove that the medication causes birth defects.

According to the Organization of Teratology Information Specialists, however, a study performed on over 2,000 pregnant women who took Zoloft shows a link between the drug and the risk of birth defects. Although the study doesn’t clearly state that the drug will cause birth defects, it does show that the risk heightens at least 3 to 5%.

Another issue that arises for pregnant women who take Zoloft is that even though it’s harmful to unborn infants, mothers who are taking the medication are at risk for health problems if they suddenly stop taking the medication. In most cases, physicians will weigh the risks of compromising the mother’s health as well as the baby before advising the mother the best route to take. For instance, the consequences of depression on a mother left untreated may be more hazardous than the potential risks for birth defects, such as suicide and the inability to take care of herself, therefore placing the infant at risk for improper prenatal care.

In addition, mothers who suddenly stop taking the medication are at risk for:

  • Miscarriage
  • Preeclampsia
  • Early labor and deivery

Zoloft Risks for Infants

As mentioned earlier, an informed decision must be made if women are taking Zoloft while pregnant. While the aforementioned risks to pregnant women are an alarming possibility, infant birth defect risks are also present, including:

  • Craniosynostosis
  •  Heart defects, including hypoplastic left heart syndrome and coarctation of the aorta
  • Tetralogy of fallot (TOF)
  • Autism
  • Respiratory problems
  • Club feet
  • Cleft lip and/or pallate
  • Spina Bifida

In addition, research shows that infants exposed to Zoloft in utero are at higher risk for restlessness, poor feeding habits, insomnia, agitation, and high-pitched crying.

Breastfeeding and Zoloft Risks

While infants can be exposed to Zoloft via breast milk, the quantity is substantially lower than in utero exposure. Some physicians state that it’s safe to breastfeed while taking Zoloft as no traces are certain ingredients of the drug are present in breast milk. Yet, a meta-analysis study of 337 cases indicates that Zoloft can indeed be found in breast milk, and since the risks of birth defects have been found during prenatal exposure to the drug, breastfeeding should be given the same consideration.

With the current known risks of Zoloft to unborn infants, many experts recommend women thoroughly discussing their options in regards to breastfeeding beforehand. While there still isn’t enough information available as to whether breastfeeding heightens the risk of birth defects, the correlation between the risks to an unborn babies and Zoloft should always be taken into consideration.

Other Antidepressant Medications Associated with Birth Defect Risks

In addition to Zoloft, several other SSRI medications have been associated with a heightened risk of birth defects, including:

  • Lexapro
  • Celexa
  • Paxil
  • Accutane
  • Symbyax
  • Prozac

If Birth Defects Occur, Who is at Fault?

For several years now, there has been evidence that select antidepressant medications heighten the risk of birth defects. Physicians have the duty and obligation to inform pregnant women of the adverse effects of taking Zoloft. Doctors rarely prescribe Zoloft to women who are already pregnant. In fact, the majority of physicians will mandate that their patients sign a waiver that they are not pregnant and do not plan to become pregnant for at least three years. Yet, in some cases, physicians fail to inform mothers of the risks associated with Zoloft and fail to inform them of other choices. In these instances, the physician may be liable for damages.

Furthermore, the company who created Zoloft, Pfizer, may also be responsible. In fact, in there are currently several hundred pending birth injury lawsuits against Pfizer, which claim that the manufacturers failed to warn consumers about the risks of birth defects, many of which are life-threatening.


hibitors (SSRIs