FDA Forces New Warning for Zoloft Birth Defect Risks

Wednesday, September 23, 2015

According to recent court filings, the FDA has ordered Pfizer to add new warnings to its popular antidepressant Zoloft that the drug may cause certain birth defects when taken during pregnancy.

The move comes as Pfizer continues to deny their drug poses any risk to fetuses, although they now face hundreds of lawsuits from families alleging birth defects.

The warning centers around the risk of septal defects, which causes a hole to develop in an infant’s heart. These may appear as atrial septal defects or ventricular septal defects, depending on the location.


ASD and VSD Heart Defects

Septal defects may be minor, resolving on their own with no treatment, or can be severe enough to require open heart surgery. They are rather common, occurring in around 1% of newborns. However, it has long been suspected that antidepressant drugs add to the risks.

The link reportedly surfaced during internal studies conducted by Pfizer itself years ago, but haven’t been disclosed until now. In a 2014 email, the company’s associate medical director Francesca Kolitsopoulos warned executives that Zoloft’s label may need a change to address heart deformities.

Current Zoloft Label Denies Birth Defect Link

Currently, Zoloft’s label states that there are “no adequate and well-controlled” studies of pregnant women. And, regulators have stated the majority of studies do not show any link between the drug and birth defects.

However, legal experts point out that a majority of research is funded by the drug industry itself.


Hundreds of Zoloft Lawsuits Pending in U.S.

Pfizer currently faces over 300 lawsuits from families with children born with birth defects ranging from heart malformations to cleft palate after using the drug during pregnancy. Experts warn that the first trimester is the most crucial time for drug side effects as that is when the organs develop.

The cases have been filed in several state courts, as well as a special federal multidistrict litigation court in the Eastern District of Pennsylvania. The federal case is known as In Re: Zoloft Products Liability Litigation, 12-md-02342, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).

So far, Pfizer has prevailed in the first two state cases to advance to trial in St. Louis and Philadelphia. However, with federal cases scheduled to start trial in early 2016, experts believe this new warning may be a big boost for victims hoping to recover medical costs and suffering.

Lawyers say those women that took Zoloft during pregnancy and gave birth to children with defects may be entitled to significant compensation, especially considering the latest FDA warning. They are offering to help those affected investigate and file claims, and there is no cost unless compensation is awarded.

DrugNews will continue to update any new research or warnings related to Zoloft or other antidepressant drugs. For more information or to speak with a Zoloft lawyer, contact us today.



Koons, C. Pfizer Weighing FDA Request to Change Zoloft's Warnings. Bloomberg News. (September 17, 2015). Retrieved from www.bloomberg.com

Wasserman, E. FDA asks Pfizer for Zoloft label update highlighting birth defect risks. FiercePharma. (September 18, 2015), retrieved from www.fiercepharma.com


Birth Defects

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