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Drugs & Medical Devices

FDA Wants Zoloft Birth Defect Warnings on Label

— October 9, 2015

Pfizer is grumpy because the FDA wants to add additional cautionary information for pregnant women to the Zoloft label. Despite internal memos stating that the Big Pharma giant’s own scientists have been warning management for years that there are increased risks for birth defects, Pfizer is resistant to the label change, stating that there isn’t enough data to support it.

Pfizer is being “strongly urged” by the FDA to add more information to the label for its multi-billion dollar drug, Zoloft. The Big Pharma giant isn’t too happy with this idea, claiming that there is no new data or results of litigation to support the change. Nevertheless, the FDA wants Zoloft birth defect warnings on label.

The increased risk of certain cardiac and septal birth defects is greatest when pregnant women take Zoloft in their first trimester. Pfizer is currently facing a slew of lawsuits over the birth defects, consolidated in a multidistrict litigation (MDL) in federal court in Pennsylvania. The drug giant insists the FDA’s label change plan is motivated by the agency’s desire to re-label pregnancy information on all prescription drugs.

The proposed label change isn’t really that damning when one reads it. The new Zoloft label would emphasize that the “weight of evidence” shows not difference in major birth defects between babies borne to women who did not take Zoloft and those who did. It would also include the statement that “an increased risk of congenital cardiac defects, specifically septal defects . . . was observed in some published epidemiological studies” of pregnant women on Zoloft in the first trimester and list certain caveats about those studies’ limitations.

Pfizer is holding the line though, arguing that there simply isn’t enough research to support these conclusions. This, despite the fact that Zoloft litigation recently brought to light internal memos that Pfizer’s own scientists have been warning management for years that Zoloft may cause congenital birth defects.


In December, the FDA issued a final ruling that Big Pharma must list more clearly the risks of using drugs such as Zoloft during pregnancy. It said the new rule established “detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.”

Pfizer is being sued for failing to warn patients about the potential risks of birth defects when taking Zoloft while pregnant. The suits totaled 545 as of July this year and include claims such as cardiac defects, spinal malformation, pulmonary hypertension, lung, abdominal & cranial defects, as well as septal defects.

A test trial (bellwether trial) will likely start in January 2016. While the decisions made in that trial are not binding on other Zoloft suits, they will help parties decide how best to proceed.


FDA Calls For Zoloft Label To Include Heart Defect Risks

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