Zoloft Pregnancy Warnings for Infant Heart Defects May Be Added to Label

Pfizer may soon add new label warnings to their popular antidepressant, providing information about studies that suggest pregnancy side effects of Zoloft may increase the risk of infant heart defects.

According to a report by Bloomberg News, the FDA has requested that the drug maker add data to the Zoloft pregnancy warnings about the findings of studies that linked the antidepressant to congenital heart problems.

Pfizer indicates that the request came from the FDA last month, as part of the agency’s recent rule changes for pregnancy and lactation labeling information, issued in December 2014.

While the drug maker has maintained that there is no reliable scientific evidence linking Zoloft and birth defects, Pfizer is currently weighing the request.

The request comes as Pfizer continues to fight several hundred Zoloft lawsuits filed by families nationwide, which allege that women were provided inadequate pregnancy warnings at the time they took the popular antidepressant.

According to internal memos uncovered during the Zoloft litigation, the company’s own scientists have warned for years that the drug may cause birth defects.

In April 2014, a review by Francesca Kolitsopoulous, associate director of Pfizer’s Worldwide Safety Strategy department’s epidemiology group, warned executives at the pharmaceutical company that studies showed a link between Zoloft side effects and heart defects, suggesting that the drug’s label should be modified to add information from the studies.

Prior to that report, Pfizer reviewers warned the company of congenital birth defects that were potentially related to Zoloft in an October 1998 report.

Zoloft (sertraline) is one of the most widely prescribed medications in the United States, and has been used by tens of millions of individuals. However, several studies have suggested that use of Zoloft by pregnant women has been linked to a potential increased risk of serious and potentially life-threatening birth defects and malformation for children.

A series of Zoloft trials are expected to begin early next year in the federal court system, where all cases filed nationwide are centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania, as part of an MDL or Multidistrict Litigation.

While individual verdicts returned in these early “bellwether” trials are not binding on other cases, they may influence any eventual settlement negotiations. Following a series of bellwether trials in the MDL, if Pfizer fails to settle Zoloft lawsuits or otherwise resolve the litigation, the drug maker may face hundreds of individual lawsuits in U.S. District Courts nationwide for individual trials.