Zoloft (sertraline) is a popular medication used to treat depression as well as obsessive-compulsive, social anxiety and panic disorder. Zoloft is manufactured by Pfizer Inc. and also marketed as Lustral, Serlain, and Asentra. However, the drug may increase the risk of the following birth defects when taken during pregnancy:
- Congenital heart defects
- Septal heart defects
- Craniosynostosis (premature fusion of skull bones)
- Omphalocele (abdominal wall defect)
- Persistent pulmonary hypertension of the newborn [PPHN]
- Spina bifida
A study in the New England Journal of Medicine found that women who took Zoloft during the first trimester of pregnancy were six times more likely to deliver a baby with omphalocele. For septal heart defects, using Zoloft doubled the risk. Zoloft poses the greatest danger to a fetus when taken during the third trimester; also, the risk of premature labor increases during this time.
Currently, Zoloft is classified by the FDA as a Category C drug - meaning that studies on animals have shown a potential birth defect risk, but the potential benefits of the drug may outweigh the risks.
General information on birth defects
Some medications contain teratogenic substances which may cause birth defects if taken during pregnancy. There are three ways that teratogenic drugs can cause birth defects. Some can cause damage to the fetus, resulting in abnormal development. Other drugs interfere with the amount of oxygen and nutrients supplied to the fetus (leading to low birth weight and underdevelopment). Lastly, some drugs can trigger contractions which can injure the fetus or cause premature birth. Usually, teratogenic drugs are most harmful to the fetus early on in the pregnancy. However, some drugs are dangerous to the fetus when taken at any time during the pregnancy. Drugs taken 20 days or more before conception may either have no effect, or induce miscarriage.
The FDA uses five pregnancy categories to classify drugs according to the risk of harm to a fetus when taken during pregnancy. Categories "A" and "B" mean that there is no evidence that the drug poses a risk to a fetus. Category C means that studies on animals indicate a possible adverse effect on the fetus, but the potential benefits of the drug may outweigh the risk. Category D means that there is positive evidence of human fetal risk, and Category X means that women who are or could become pregnant should not take this drug (i.e. Accutane). Drugs that the FDA has not yet classified are in Category N.
If your child suffers from birth defects that may have been caused by Zoloft use, please contact us today. The attorneys at Oshman & Mirisola, LLP have successfully handled birth defect cases for more than 35 years. Please call (800) 400-8182 or fill out and submit our online Contact Us form for a free initial consultation.