The U.S. Food and Drug Administration (FDA) is urging Pfizer to add warning information to the label of its multi-billion dollar antidepressant drug, Zoloft.
The agency requested that Pfizer change the warnings section of the drug’s prescribing information to include the findings of researchers who found an increased risk of congenital heart defects in newborns whose mothers took Zoloft during pregnancy.
The pharmaceutical giant claims there isn’t enough research or results of litigation to support the change and insists the request is motivated by the FDA’s initiative to re-label pregnancy information on all prescription drugs.
Pfizer is currently facing more than 1,000 lawsuits from plaintiffs who allege the drug maker failed to warn patients and doctors about the drug’s potential impact on unborn babies. The FDA-requested label change could lend support to the claims of Zoloft’s association with congenital birth defects.
A Pfizer Inc. report disclosed during a Zoloft trial last June showed that a company scientist warned executives in 2014 of a possible link between the drug birth defects and recommended changes to the safety warning.
Despite the FDA request and mounting claims, Pfizer maintains that Zoloft does not cause heart defects in babies, and that its label provides doctors and women adequate warning of the medication’s risks. Zoloft’s current label states there are “no adequate and well-controlled” studies of pregnant women.
An early trial date for the first Zoloft lawsuit filed in federal court is scheduled for March 2016. The lawsuit, known as a bellwether case, is essentially a test to see how the major lawsuit will play out for all parties involved.