Pfizer Failed To Warn About Zoloft Birth Defects. Pfizer has been named in another Zoloft birth defect lawsuit, this time by a couple in Louisiana. Terry and Nelda Rolling claim Nelda’s use of Zoloft during pregnancy caused their child to be born with a congenital birth defect.
Zoloft, known as selective serotonin reuptake inhibitors (SSRI) antidepressant, is approved by the U.S. Food & Drug Administration (FDA) to treat major depression (MDD), social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, premenstrual dysphonic disorder (PMDD), and obsessive-compulsive disorder (OCD) in adults and OCD in 6 to 17 year olds.
Zoloft was approved in 1991, and by 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the U.S.
A number of studies have linked SSRI antidepressants, including Zoloft, to birth defects.
The FDA warned that women who use the antidepressant Zoloft
In July 2006, the FDA warned that women who use the antidepressant Zoloft after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), following the publication of a study in the New England Journal of Medicine that examined the risk of birth defects with Zoloft and similar antidepressants.
The Rollings’ complaint accuses Pfizer of failing to adequately warn of the drug’s risks, and of concealing, suppressing, and failing to disclose dangers.
They allege Pfizer knew as early as 1996 that Zoloft could cause a variety of problems in children exposed to the antidepressant before birth. Evidence that Zoloft could harm a developing fetus continued to mount between 2002 and 2006.
By 2007, due to the publication of a study in the New England Journal of Medicine, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken during pregnancy, the lawsuit claims.
The Rollings joins dozens of other families who are suing Pfizer over alleged Zoloft birth defects. According to the company’s own count, at least 59 such lawsuits are currently pending in federal courts throughout the U.S.