SSRI Litigation

Zoloft Warnings for Women

Zoloft® is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It is designed to balance the levels of serotonin in the brain, elevate mood and stabilize emotions. Doctors prescribe it for various disorders, including depression and anxiety.

Zoloft and other SSRIs have been found to increase the risk of birth defects among pregnant women. Because of this, the U.S. Food and Drug Administration (FDA) requires warnings on labels. The agency also cautions doctors to weigh benefits and risks before prescribing Zoloft to patients who are pregnant.1

SSRI medications may pose additional risks to infants during breastfeeding, but research on Zoloft and breast milk has been inconclusive so far.

Breastfeeding and Zoloft

Recent studies have shown a "low to very low risk" of infant exposure to antidepressants through breast milk, though the level of exposure varies according to the chemical ingredients in particular medications.2 Clinical studies on sertraline, the main ingredient in Zoloft, have either been inconclusive or showed negligible amounts in breast milk.3 Even so, the FDA advises doctors to use their best judgment in prescribing Zoloft to breastfeeding mothers.

Zoloft and pregnancy

A more immediate concern is the use of Zoloft among pregnant women. While certain effects of the drug may not be known, some medical journals have reported findings about the effects of Zoloft on developing fetuses. Babies born to women who use Zoloft and other SSRIs show an increased risk for birth defects.4

Confirmed Zoloft-related birth defects include:

  • Skull bone malformation
  • Cleft lip
  • Cleft palate
  • Serious congenital heart problems
  • Intestines forming outside of the abdomen
  • Abnormal brain development
  • Persistent pulmonary hypertension (PPHN)

In the case of PPHN among newborns, the condition is fatal in one out of every 10 cases. Pregnant mothers who use Zoloft are at twice the risk for having children with heart defects.5

Related lawsuits

Hundreds of individual birth defect lawsuits have been filed nationwide against Pfizer, the maker of Zoloft. In Pennsylvania, a multidistrict litigation case specifically for Zoloft-related birth defects was filed in 2011, and now 250 lawsuits are pending in this federal court.

If you are taking Zoloft and either pregnant or planning to get pregnant, you should talk to your doctor. Additionally, if you have a child with birth defects that may be linked to the use of Zoloft, you could be eligible for legal compensation. Contacting an experienced attorney is the first step in protecting your legal rights; your lawyer can examine the facts of your case and assist you in filing a claim.

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