What does Zoloft “Pregnancy Category C” mean?

Zoloft is listed as a “Pregnancy Category C” medication by the U.S. Food and Drug Administration (FDA). What does that mean for you?

The pregnancy category of a drug indicates the FDA’s assessment of the fetal injury (birth defects) risks of the drug. There are five FDA pregnancy categories:

Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C: 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

As a FDA Pregnancy Category C drug, use of Zoloft during pregnancy clearly is linked to birth defects risks. Therefore, an issue for patients and doctors is whether the benefits of the antidepressant drug outweigh those risks.

Another issue that is getting increasing attention of drug lawsuit attorneys, the public, and the FDA is whether Pfizer has fully disclosed all Zoloft pregnancy risks. Lawyers representing parents of children who have suffered Zoloft birth defects claim that Pfizer has known that Zoloft use during pregnancy may increase the risk of birth defects, but covered up research findings and failed to warn of the risks and dangers of its popular SSRI antidepressant.

Zoloft lawsuit attorneys seek financial compensation for Zoloft birth defects damages under several theories of legal liability, including strict product liability, fraud, false advertising, breach of warranty, unjust enrichment, negligence, and wrongful death.

If your child suffered birth defects after Zoloft use in pregnancy, you may be entitled to a substantial financial recovery. There are time limits to filing a Zoloft claim for birth defects compensation. It is important to learn your legal options as soon as possible.

Contact us today to speak with an experienced Zoloft lawsuit attorney. Get a free, confidential consultation. We are available 24 hours a day to discuss your legal options.