Developed and manufactured by Pfizer, Zoloft (sertraline) is a drug used to treat a wide range of issues including depression, post-traumatic stress disorder, panic attacks, morning sickness, and various anxiety disorders. Zoloft belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRI), which have become the most widely prescribed class of antidepressant medications in the United States. Upon receiving FDA approval, Pfizer marketed Zoloft as being more efficient and powerful than previous antidepressant medications. However, it also has many adverse side effects, and women taking the drug while pregnant reported the most dangerous side effects including nausea, vomiting, seizures, hallucinations, and uneven heartbeats. Some of the most dangerous repercussions of taking Zoloft while pregnant are the severe and sometimes deadly birth defects it has been linked to, including:
- Cardiac Septal Defects
- Lung defects
- Cleft palate
- Cranial Defects
- Persistent Pulmonary Hypertension
Though introduced in 1991, it took more than a decade for the link between Zoloft and dangerous birth defects to become public knowledge. In December of 2005, the FDA issued a public advisory based on U.S. research that infants that were exposedto Zoloft in the womb had a substantial increase in risk of congenital heart defects. These defects were largely atrial and ventricular septal defects. Septal defects are conditions in which the walls of the infant’s heart are not completely formed. In several large case-controlled studies, it was determined that the use of Zoloft by a mother during the first trimester led to a 6-fold increase in the risk of omphalocele (defect of abdominal organs), a 4-fold risk to the fetus of having a congenital limb defect, and a 2 to 3-fold risk of a cardiac septal defect.
In 2006, the FDA issued yet another advisory based on a study indicating that a mother’s use of Zoloft during pregnancy increased the risk of Persistent Pulmonary Hypertension (PPHN) in newborns by 6-fold. PPHN is a high blood pressure in the lungs of infacts that causes blood in the pulmonary artery to bediverted away from the lungs to the newborn’s other organs, and is a life threatening condition. Given that the prevalence of major depressive disorders in women ofreproductive age is thought to be 10-15%, it is probable that a large number ofpregnant women are taking Zoloft. Potential side effects, including the development of birth defects in the fetus, have been reported to occur when the drug is taken as early as the first trimester, a time when many women do not yet realize they are pregnant.
As of June 2015, Pfizer faced over 1,000 lawsuits related to possible birth defects from Zoloft. These lawsuits have been consolidated in Pennsylvania as a multidistrict litigation (MDL), allowing them to be more efficiently handled. This MDL has been active since 2012 and is accepting more suits. Pfizer had a duty to more thoroughly test Zoloft and give people sufficient safety warnings about all potential side effects, including birth defects. While defective drug litigation can be challenging and complex, the attorneys at Pope McGlamry have the experience and expertise to ensure you receive the compensation to which you are entitled. For a confidential case evaluation, please call (Atlanta-877-285-7656 or Columbus-877-265-7656) or contact us online.