ZOLOFT belongs to a family of drugs known as SSRI’s (selective serotonin reuptake inhibitors).  These medications are frequently used to treat depression, anxiety, personality disorders, obsessive compulsive disorder, post-traumatic stress disorder, and other conditions.  Zoloft was one of the first of the drugs in this family that was approved and the patent holder was Pfizer.

Although Zoloft was only approved for the treatment of “major depressive disorder” which the American Psychiatric Association categorizes as debilitating depression, it is too frequently prescribed for mild depression.  Zoloft has not been shown to be very effective for treating mild depression.  In 2005, Pfizer’s sales of Zoloft were in the area of $2.5 billion per year.  By 2006, their patent expired and a number of generic manufacturers began to sell “Sertraline” under various generic names.

  • In September 2005, Pfizer issued a letter to the doctors warning them Zoloft use in the first trimester causes congenital birth defects.
  • On December 8, 2005, the FDA issued a warning that Zoloft causes birth defects to the heart based on Australian and Swedish studies.
  • In July 2006, the FDA issued a warning that the use of any SSRI, including Zoloft, could be associated with a 600 percent increase in primary pulmonary hypertension (PPHN) if used in the second or third trimester.
  • In 2007, Pfizer changed its Physician’s Desk Reference warning for birth defects.
  • On August 27, 2008, the FDA recategoried Zoloft as a “pregnancy category C” drug, acknowledging that there were conclusive animal studies showing that Zoloft caused birth defects.

Unfortunately, Pfizer continues to maintain that there are no definitive studies that Zoloft causes birth defects in human beings and has, therefore, recommended that Zoloft be used during pregnancy if the benefit of the drug justifies the risk of potential birth defects.


Other studies have linked Zoloft exposure to the following birth defects:

  • Anencephaly
  • Cardiomyopathy
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Bicuspid Aortic Valve
  • Tricuspid Stenosis
  • Cleft Mitral Valve
  • Coarchation of the Aorta
  • Craniosynostosis (baby’s skull closes too soon)
  • Omphalocele (baby born with organs outside abdomen)
  • Ventricular Septal Defects
  • Atrial Septal Defects
  • Tetralogy of Fallot (TOF)

Zoloft has also been linked to other types of birth defects.

If you believe your child’s birth defect may be a Zoloft birth defect, and you were using any SSRI medication, including Zoloft, Paxil, or any generic form of an SSRI medication, contact the Baltimore birth defect lawyers at The Yost Legal Group for a free initial consultation in Maryland.

Free consultation: Call 1-800-YOST LAW or complete the contact form below to learn more about how we can help.