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Studies published on SSRI antidepressants and birth defects

A pair of respected medical journals published studies within the last couple of months that linked the expectant mother's use of selective serotonin reuptake inhibitor antidepressants with certain birth defects. The findings were released while SSRI antidepressant lawsuits have been filed against the makers of some of these popular drugs. Plaintiffs alleged the birth defects connection.

Pregnant Ultrasound.jpgThe most recent of these studies delivered a blow to prenatal use of Paxil (paroxetine) and Prozac (fluoxetine).

The British Medical Journal released a summary of a study July 8 that combined the results of numerous published analyses with data collected from a National Birth Defects Prevention Study, which incorporated findings from 10 U.S. medical centers for nearly 28,000 births that took place between 1997 and 2009. The study noted 14 categories of birth defects that, according to medical scientific literature, had been associated with SSRI use.

The BMJ researchers concluded that some of the findings "suggest that some birth defects occur 2-3.5 times more frequently among the infants of women treated with paroxetine (Paxil) or fluoxetine (Prozac) early in pregnancy."

The authors explained the phenomenon in more detail as follows: "For fluoxetine treatment, associations were seen for ventricular septal defects, right ventricular outflow tract obstruction cardiac defects, and craniosynostosis. Paroxetine had the most previously reported associations, and significant associations were observed for five of the seven defects assessed. Associations between paroxetine and anencephaly, atrial septal defects, and right ventricular outflow tract obstruction cardiac defects found in other studies were confirmed in this independent dataset, and two other associations seen in the previous NBDPS analysis (gastroschisis and omphalocele) were again seen in this analysis."

Meanwhile, Zoloft, another SSRI antidepressant, is also the subject of SSRI antidepressant lawsuits. Indeed, more than 500 pending Zoloft lawsuits as of July were centralized for pretrial proceedings at U.S. District Court for the Eastern District of Pennsylvania. And those actions have been a relative handful of the Zoloft lawsuits that have been filed nationwide.

The U.S. Judicial Panel on Multidistrict Litigation established this multidistrict litigation court in 2012. In so doing, the panel of federal judges held that these Zoloft lawsuits "involve allegations that Zoloft, a prescription medication approved for the treatment of depression and other ailments, causes birth defects in children when their mothers ingest the drug while pregnant."

The American Journal of Obstetrics and Gynecology published for its June 2015 edition a summary of a study that researchers in Quebec, Canada, conducted from 1998 through 2010.

Spearheaded by Montreal-based Sainte-Justine Hospital, the research set out to settle a medical scientific discourse about the potential link between Zoloft, which goes by the generic sertraline, and birth defects.

"Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by Food and Drug Administration warnings," the objective reads, "we aim to quantify the association between first-trimester exposure to sertraline, a first-line treatment, and the risk of congenital malformations in a cohort of depressed women."

The Canadian researchers examined a cohort of more than 18,000 pregnancies. Some were exposed to Zoloft, some to other SSRIs, and, of course, there were some pregnancies exposed either to a non-SSRI antidepressant or to no antidepressant.

Looking at the incidence and types of birth defects relative to the types of exposures, researchers concluded, "Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression. Nonsertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects."

Any mother who used an SSRI antidepressant during pregnancy - including Zoloft, Paxil, Prozac, Celexa and Lexapro - and who had a child with birth defects may want to discuss with a pharmaceutical injury attorney whether she and her child are entitled to compensation for the cost of medical treatment and for other recoverable damages.

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