What is Zoloft?
Zoloft (sertraline) is an antidepressant medication that has been sold by Pfizer Inc. since 1991. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which treat psychiatric disorders by increasing levels of serotonin in the brain. It is used to treat depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and more.
Zoloft and Pregnancy
Zoloft is “Pregnancy Category C,” which means that animal studies have shown harm to a fetus, but the risk in humans is unknown. During pregnancy, Zoloft is known to pass through the placenta and the baby’s blood-brain barrier. Experts know this because studies indicate that up to 30% of babies exposed to Zoloft through the third trimester are born with symptoms of withdrawal (agitation, tremors, high-pitched crying, convulsions, poor feeding and sleeping, and more).
Studies Linking Zoloft and Birth Defects
Numerous studies have associated Zoloft with an increased risk of birth defects, particularly heart defects and abdominal defects. These studies include:
- Clinical Epidemiology (2010): Zoloft linked to an increased risk of “hole-in-the-heart” defects (also known as septal heart defects) septal heart defects.
- British Medical Journal (2009): Zoloft linked to a 2.5-fold increased risk of septal heart defects.
- New England Journal of Medicine (2007): Use of SSRIs during pregnancy was linked to a 2.4-fold increased risk of anencephaly, 2.5-fold increased risk of craniosynostosis, and a 2.8-fold increased risk of omphalocele.
- New England Journal of Medicine (2007): Linked first-trimester use of Zoloft to a 2.4-fold increased risk of clubfoot, a 4.4-fold increased risk of anal atresia, and a 3.9-fold increased risk of a limb-reduction birth defect.
- New England Journal of Medicine (2007): Zoloft linked to a 5.7-fold increased risk of omphalocele.
FDA Warning for Zoloft and Persistent Pulmonary Hypertension of the Newborn (PPHN)
In 2006, the U.S. Food and Drug Administration (FDA) published a Public Health Advisory about the link between Zoloft and Persistent Pulmonary Hypertension of the Newborn (PPHN), a life-threatening lung defect that is fatal in 10% of cases. Zoloft and other SSRI antidepressants were associated with a six-fold increased risk of PPHN. However, in 2011, the FDA published an update after reviewing studies giving conflicting results linking antidepressants and PPHN.
Pharmaceutical companies have an obligation to warn women and their doctors about the risks of taking a medication during pregnancy. When they fail to do so, victims have a right to seek financial compensation for their injuries. Although filing a Zoloft lawsuit can never heal the devastating results of a serious birth defect, it can help you and your family pay for medical bills and future treatment of your child. In addition, you can have the satisfaction of holding a pharmaceutical company accountable for putting corporate profits over public safety.
Zoloft Lawsuits Centralized in Federal Litigation
If you decide to file a Zoloft lawsuit, you won’t be alone. Since April 2012, over 400 lawsuits have been filed in a federal Multi-District Litigation (MDL No. 2342) in the U.S. District Court for the Eastern District of Pennsylvania: In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation. All of the lawsuits allege that Zoloft causes birth defects in children when their mothers take the drug during pregnancy.
Zoloft Lawsuit Settlement Information
Women who filed lawsuits for birth defects caused by Paxil, an antidepressant that is similar to Zoloft, were awarded average settlements of $1.2 million per case, or $1 billion total. Pfizer is not currently settling Zoloft lawsuits; instead, lawyers will select certain cases for “bellwether” trials. However, Zoloft lawsuit settlements could be reached before trials begin.
Zoloft Birth Defects
- Heart Defect
- Septal Heart Defects
- Atrial Septal Defect
- Ventricular Septal Defect
- Hole in the Heart
- Tetralogy of Fallot
- Pulmonary Atresia
- Transposition of the great vessels
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Aortic Stenosis
- Coarctation of the Aorta
- Heart Murmur
- Tricuspid Valve Atresia
- Ebstein’s Anomaly
- Truncus Arteriosus
- Patent Ductus Arteriosus
- Mitral Valve Prolapse
- Abdominal Defects
- PPHN (Persistent Pulmonary Hypertension of the Newborn)
- Skull Defect
- Neural Tube Defects
- Spina Bifida
- Physical Malformations
- Limb Defects
- Cloacal Exstrophy
- Esophageal Atresia
- Esophageal Stenosis
- Undescended Testes
- Anal Atresia
- Premature Birth
- Neonatal Withdrawal
- Cleft Lip
- Cleft Palate
- Intellectual Disability
- Infant Death