A lawsuit was filed on behalf of the parents of a child who they say was born with a number of heart defects, which resulted from the use of Zoloft. This drug is a selective serotonin reuptake inhibitor (SSRI) used to treat depression and/or anxiety. Although some research has indicated there could be a link between the use of Zoloft during pregnancy and persistent pulmonary hypertension of the newborn or heart defects of the septum, these links have yet to be confirmed. The risks now appear to be very low, but some risk means there could be some danger.
The lawsuit filed in a Texas district court claimed the drug company Pfizer was aware of Zoloft’s potential side effects, or should have been. It says the drug manufacturer did not properly warn the public of potential side effects such as heart defects. The parents involved in the suit said they were led to believe the drug is perfectly safe to take during pregnancy. They also say a number of conditions their daughter was born with—including hypoplastic right ventricle, right coronary ostial atresia, pulmonary atresia and patent ductus arterioles—were caused by the drug being used during pregnancy.
According to the Children’s Heart Institute, a hypoplastic right ventricle is a small and weak right ventricle or chamber. The right ventricle’s normal growth was blocked in the early heart development, when the tricuspid valve did not open. Right coronary ostial atresia is rare and occurs only in about one to two percent of congenital heart disease cases. Pulmonary atresia occurs when the valve on the right side of the heart is blocked so blood cannot flow properly. Each one of these conditions is serious enough on its own, but having multiple heart defects at the same time is extremely challenging.
When the mother in the case asked her physician about the side effects of Zoloft during pregnancy, the lawsuit claims she was told there were none. Allegedly, Pfizer knew of such side effects but did not disclose them until sometime later.
Several studies have attempted to examine the relationship between SSRIs and birth defects, such as one conducted in 2007 at the Slone Epidemiology Center at the University of Boston, but this one found the association may only be possible. A different study conducted earlier did find some association and said further study was needed. Both were published in the New England Journal of Medicine.
There are so many factors at play, both medically and legally speaking, it is very difficult to predict if the case in Texas could be a precedent for later class action lawsuits.