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FDA Requests Warning on Zoloft Labels

FDA requests warning label on ZoloftZoloft (sertraline) is an anti-depressant known as a selective serotonin reuptake inhibitor (SSRI) and is used to treat depression, OCD, panic disorder, PTSD, anxiety, and premenstrual dysphoric disorder. Zoloft, produced by Pfizer, has been on the market since 1991. However, for years now, some studies have shown that the use of Zoloft by pregnant women is associated with an increased risk of the child being born with a serious birth defect.

A recent article in Bloomberg Business, discusses the FDA’s request that Pfizer modify its safety warnings on Zoloft and acknowledge that studies have linked the drug to heart defects in newborns. Accordingly, this request was part of an initiative by the FDA to edit drug labels across the pharmaceutical industry regarding use during pregnancy and lactation. This initiative, or final rule, intends to set standards for presenting information about using medicines during pregnancy and breastfeeding on the labels of prescription drugs and biological products. The new content and formatting requirements are intended to provide a more consistent way to include “relevant information about the risks and benefits of prescription drugs” used during pregnancy and breastfeeding.

Currently, drugs are labeled on a letter system (A, B, C, D, and X) to classify the risks associated with the medication if used during pregnancy. For example, Zoloft is currently a pregnancy category C, meaning animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category X means there is positive evidence of human fetal risk based on adverse reaction, and the risks involved in use of the drug in pregnant women clearly outweigh any potential benefits.

The new labeling would require a pregnancy subsection providing information on the use of the drug by pregnant women, such as “dosing and potential risks to the developing fetus, and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected” when they use the drug. The FDA notes that information in drug labeling “about the existence of any pregnancy registries has been previously recommended but not required until now.” The subsection will also include three subheadings: “risk summary,” “clinical considerations” and “data.”

The FDA additionally has a draft guidance for the industry to help manufacturers comply with the new labeling content and format requirements from being brought.

The Bloomberg article then goes on to mention whether this new labeling, which Pfizer is considering, will help substantiate current lawsuits against the manufacturer, or prevent future lawsuits.

At McDivitt Law Firm, we feel that you deserve information that may be relevant to your rights as a consumer, and hope that future drug labels reflect the risks associated with the drug.

For more information on Zoloft and other SSRIs, check out

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