Study Finds Zofran Pregnancy Complications May Include Heart Birth Defects

Published on March 16, 2015 by Sandy Liebhard

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A study published late last year in Reproductive Toxicity indicated that there might be a link between Zofran and heart defects when the anti-nausea medication is used to treat expectant mothers in their first trimester of pregnancy. The research, which was conducted by scientists from Sweden’s National Board of Health and Welfare, reported that such children were 62% more likely to experience heart problems compared to babies who weren’t exposed to Zofran in early pregnancy.

According to their study abstract, the research team identified 1,349 infants included in two Swedish health registries, all of whom were born to women who used Zofran early in their pregnancy between 1998 and 2012. Zofran did not appear to increase the risk of birth defects overall, but the analysis did identify a specific association with cardiovascular malformations. While the prevalence of such defects rose by 62%, the researchers found that the babies exposed to Zofran were twice as likely to experience a septal defect, such as atrial or ventricular septal defects.

[I]f an association between the use of ondansetron and an increased risk for cardiovascular defects is true, the strongly increasing off label use of the drug at nausea and vomiting in early pregnancy must be regarded as unsuitable and should be avoided,” the authors of the study wrote.

Currently, the U.S. Food & Drug Administration (FDA) has placed Zofran in Pregnancy Category B, which indicates that its use in pregnant women has not been well studied. While the drug is not approved to treat expectant mothers, Zofran is often use “off-label” to prevent nausea and vomiting associated with pregnancy.

Zofran Litigation

In recent months, a number of Zofran lawsuits have been filed in U.S. courts on behalf of children who were allegedly born with serious congenital abnormalities due to their mothers’ use of the medication in early pregnancy. Among other things, the lawsuits accuse GlaxoSmithkline of concealing information pointing to an association between Zofran and birth defects, and of improperly promoting its use to treat pregnant woman suffering from nausea and vomiting. While only a handful of these claims have been filed thus far, some legal experts believe the litigation surrounding Zofran could become quite large.

The nationwide law firm of Bernstein Liebhard LLP is now investigating Zofran lawsuits involving the following problems:

  • Cleft palate/cleft lip
  • Heart defect
  • Club foot/hand
  • Skeletal defect (including cranial deformations)

If you’re concerned that your baby developed a Zofran birth defect, please contact our office today to learn more about filing a claim. Free case reviews may be obtained by completing the form on this page, or by calling .

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