June 5, 2015 — In the last few years, at least four studies have found evidence that using Zofran during pregnancy increases the risk of having a baby with a birth defect.

Zofran (ondansetron) is only FDA-approved to prevent severe nausea in chemotherapy or surgery patients. Since it hit the market in 1991, it has become a popular “off-label” drug for pregnant women with morning sickness in the first trimester.

The manufacturer, GlaxoSmithKline (GSK), paid a $3 billion settlement after the Justice Department accused the company of marketing Zofran to obstetricians and gynecologists as a safe treatment for morning sickness.

Now, researchers are finding more evidence that Zofran could increase the risk of birth defects when it is used in the first trimester of pregnancy. At least four studies have found a link between Zofran and birth defects:

  • A study published in 2013 by BioMed Research International found that Zofran increased the risk of birth defects by 20%, premature birth, and other adverse pregnancy outcomes (low APGAR, lower birth weight and length)
  • In 2014, a study in the journal Reproductive Toxicology found that babies exposed to Zofran were twice as likely to have a septal heart defect (also known as a “hole in the heart”)
  • Researchers from Denmark who looked at data from over 900,000 pregnancies, including 1,250 women who used Zofran in the first trimester, concluded that it doubled the risk of heart defects and increased the risk of major birth defects by 30%. About 4.7% of women who used Zofran had a baby with a birth defect.
  • A study published in Birth Defects Research by researchers from Harvard University and the Centers for Disease Control (CDC) found a 2.4-fold increased risk of cleft palate associated with Zofran.

Children who were born with birth defects after being exposed to Zofran may qualify to file a lawsuit. At least seven families have already filed individual lawsuits on behalf of children with cleft palate, heart defects, and more.


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