FDA asks Pfizer to add birth defects to Zoloft warning label

The FDA asked Pfizer in August to add heart defects risks to Zoloft’s safety warnings. In so doing, the drug giant for the first time would have to admit that there are credible studies linking use of its popular SSRI antidepressant during pregnancy to heart defects in newborns. Zoloft’s current label says there are “no adequate and well-controlled” studies of pregnant women. The new warning would acknowledge research findings that there is “an increased risk of congenital cardiac defects” in babies whose mothers took Zoloft during pregnancy.

The request to amend label was part of the FDA’s new content and formatting requirements which, according to a December 2014 FDA press release, “will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”

“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk,” said Sandra Kweder, M.D, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”

Despite research findings to the contrary, Pfizer maintains that “there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.”

According to Bloomberg, Pfizer said, “The new language, which is still in draft form, reflects the extensive science supporting the safety and efficacy of Zoloft, stating a complete review of the scientific evidence finds that there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.” In short, the company insists that the drug doesn’t cause birth defects and that it adequately warned women and their physicians about Zoloft’s risks.

Pfizer currently faces hundreds of lawsuits filed across the country by parents claiming Zoloft use during pregnancy caused their children to suffer heart defects and other birth defects and that it failed to warn the drug could cause such side effects. The proposed label change could strengthen their claims.

If your child suffered a heart defect after Zoloft use during pregnancy, you may be entitled to recover financial compensation. Contact us now to for a free no-obligation consultation with an experienced Zoloft heart defects lawsuit attorney.

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