Manufactured by Pfizer, Inc., Zoloft® is prescribed to treat major depression in adults, as well as obsessive-compulsive disorder, panic and social anxiety disorders and post-traumatic stress disorder in both adults and children. However, the use of Zoloft has been linked in various studies to an increased risk of birth defects, including:
Heart (cardiac) defects (hole in heart)
Cleft lip and/or cleft palate
Clubfoot (one or both feet turn downward and inward)
Abdominal wall defects (infant omphalocele)
Anal atresia (complete or partial closure of the anus)
Our Leadership and Experience in Zoloft Lawsuits
Motley Rice member Kimberly Barone Baden was appointed to the Plaintiffs' Steering Committee of In re Zoloft (sertraline hydrochloride) Products Liability Litigation, MDL 2342, on July 13, 2012, by the Honorable Cynthia M. Rufe. Our attorneys work with women whose children have been affected by birth defects allegedly as a result of medical drugs, including Effexor, Zofran and Zoloft.
Zoloft Studies and Background
Zoloft, generically known as sertraline hydrochloride, was approved by the FDA and introduced into the market in 1991 for use in adults ages 18 and over. In 2002, the FDA approved Zoloft to treat severe obsessive compulsive disorder in children ages six and older.
In December 2005, the FDA issued a public health advisory warning that the use of certain antidepressants during the first trimester of pregnancy may be associated with an increased risk of birth defects. The advisory was based on U.S. and Swedish studies showing that exposure to certain antidepressants increased the risk of heart defects, including atrial and ventricular septal defects; conditions in which the wall between the right and left sides of the heart is not completely developed.
Citing a study published in the New England Journal of Medicine in February 2006, Health Canada issued a strong warning in March 2006 to pregnant women or women who were trying to become pregnant that antidepressant drugs like Zoloft could potentially pose serious risks to unborn or even nursing babies.
A 2007 study published in the New England Journal of Medicine found a "significant association" between Zoloft and septal defects, which can be life threatening. According to the study, mothers who take Zoloft during pregnancy may double the risk of having a baby born with septal defects.
In another study published in the March 2010 issue of Pediatrics, researchers found a potential association between exposure to antidepressants in late pregnancy and a delay in normal motor development skills at six and 19 months of age. The same researchers, in an earlier 2009 study published by British Medical Journal, found that women who were pregnant and taking certain antidepressants during the first trimester had an increased risk of giving birth to babies with various heart defects.
In May 2010, A study conducted by scientists at the University of Montreal and published in the Canadian Medical Association Journal suggested that women who take antidepressants like Zoloft during the first trimester of pregnancy are significantly more likely to suffer a miscarriage than women who do not take antidepressants.