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Newly published study links Zoloft to birth defects


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While more than 500 Zoloft lawsuits are pending before the U.S. District Court for the Eastern District of Pennsylvania for pretrial management, a Canadian study that the American Journal of Obstetrics and Gynecology released Jan. 28 showed an association between an expectant mother’s use of Zoloft during pregnancy and the emergence of birth defects.

The U.S. Food and Drug Administration originally approved Zoloft, an antidepressant, in 1991. Zoloft, the generic version of which is sertraline, belongs to a class of drugs known as selective serotonin reuptake inhibitors, a group also linked to neonatal malformations. The SSRI class includes:

  • Celexa (citalopram)
  • Luvox (fluvoxamine)
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Viibryd (vilazodone)
  • Zoloft (sertraline)

Members of the pharmacy faculty at the Montreal-based Research Center for Sainte-Justine Hospital set out with the following objective: “Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by FDA warnings, 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 study nailed SSRIs as a whole as it singled out the generic Zoloft. The conclusion reads, “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. Non-sertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects.”

Pfizer, which makes Zoloft, is one of the defendants in Zoloft lawsuits. The pharmaceutical corporation filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to centralize the original 57 Zoloft lawsuits once located in six judicial districts before a single multidistrict litigation court, or MDL. As it grouped the federal cases before Pennsylvania’s Eastern District trial court in April 2012, the panel noted, “These actions share factual questions arising out of allegations that Zoloft causes birth defects in children whose mothers ingest the drug while pregnant. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.”

Pfizer’s alleged failure to warn about Zoloft risks is a key issue in Zoloft lawsuits. For example, one wrongful death case filed two years ago involved a Wisconsin couple whose baby girl died shortly after her birth in 2010. The alleged lack of warnings was raised.

“Under the FDA scheme,” plaintiffs alleged, “Defendants have a duty to ensure its warnings to the medical community are and remain accurate and adequate, to conduct safety surveillance of adverse events for the drug, to report any data related to the safety and/or accuracy of the warnings and information disseminated regarding the drug, and to update the label when new safety information was obtained. The package inserts for Sertraline, and the PDR [Physicians’ Desk Reference] monograph for Zoloft, contained false and/or misleading statements and omitted information material to the foreseeable and ordinary contemplated uses of Sertraline and Zoloft. False and/or misleading information was also provided by Pfizer … by way of Pfizer’s advertising, marketing materials, detail persons, seminars, presentations, publications, notice letters, and regulatory submissions.”

The plaintiffs further argue, “Had the Zoloft and/or Sertraline product information warned of the significant risks of birth defects in a developing fetus if used while pregnant, [the mother] would not have ingested Zoloft and/or Sertraline during her pregnancy and her prescribing physicians would not have prescribed Zoloft and/or Sertraline for her to use during pregnancy.”

A mother who used Zoloft and whose child suffered from birth defects may be entitled to compensation. One of the Zoloft attorneys at Reich & Binstock will provide such a parent a free consultation and will explain all of the legal options available. All one must do is request a free legal analysis. Let one of Reich & Binstock’s experienced attorneys handle the rest.

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