FDA Calls for Increased Warnings on Zoloft® Due to Drug Injury Risk

by Staff | September 28th, 2015

Zoloft® is a powerful antidepressant drug used to treat a number of mental health conditions. Women who are taking or are considering using this drug should be aware of certain congenital risks the medication may pose to their unborn children if they are, or are considering becoming, pregnant.

Research has shown an increased risk of congenital heart defects in the children who were born to women who took Zoloft during pregnancy. The U.S. Food and Drug Administration (FDA) reports the risks of this particular antidepressant birth defect were as much as six times higher in women who took the drug into the twentieth week of pregnancy as compared to women who birthed children and did not take the drug.

These findings and other research that came to similar conclusions have prompted the FDA to ask the manufacturer of Zoloft, Pfizer, Inc., to change the warning labels on the drug to include information about the increased risk of heart defects, such as persistent pulmonary hypertension, in children born to women who took Zoloft. According to Bloomberg Business, Pfizer maintains the drug is safe for women to use.

If you’re a woman who has been given a prescription for Zoloft, it’s important to be aware of your rights as a patient. If your child was harmed as the result of using the medication, you should also consider taking a look at our website to learn more about the options and resources that are available to those who have suffered a drug injury.

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