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Zofran (ondansetron) Lawsuit Help

The Law Firm of Eric H. Weinberg is currently investigating personal injury claims in which the use of Zofran (ondansetron) for the treatment of “morning sickness” during pregnancy may be linked to the occurrence of certain birth defects.

Studies suggest that the use of Zofran during the first trimester of pregnancy may increase the risk of the following birth defects:

  • Cleft Lip or Cleft Palate
  • Atrial Septal Defect (ASD)
  • Ventricular Septal Defect (VSD)
  • Other Heart Birth Defects

For a free drug lawsuit case evaluation, please contact the Weinberg Law Firm toll free at 1-877-934-6274. Since 1984, Attorney Eric Weinberg has represented personal injury and product liability victims obtaining over $800 million on behalf of those injured.

Unapproved (off-label) Use of Zofran to Treat Morning Sickness

Zofran is marketed by pharmaceutical giant, GlaxoSmithKline. Zofran has been approved by the FDA to prevent nausea and vomiting in cancer patients receiving certain chemo- or radiation therapies, and to prevent postoperative nausea in surgical patients. Zofran has not been approved by the FDA for the treatment of nausea and vomiting in pregnancy (commonly referred to as “morning sickness”), although it has been widely prescribed to women “off-label” for this indication.

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How Safe is Zofran for the treatment of morning sickness?

Zofran is designated “Pregnancy Category B” meaning that GlaxoSmithKline has not provided the FDA with human data demonstrating the safety of Zofran to mothers and their unborn babies when the drug is taken during pregnancy; and that animal data do not suggest a risk to the fetus.

Recent published data however, suggest that Zofran may increase the risk of certain birth defects including:

Cleft Palate :

  • In a large case-control study, a 2-fold increased risk for cleft palate was reported in association with Zofran when used to treat nausea and vomiting in pregnancy (NVP) in the first trimester of pregnancy.1

Cardiac Septum Defects :

  • In a review of combined data from the Swedish Medical Birth Register and Swedish Register of Prescribed Drugs, Danielsson et al, reported “The risks for a cardio-vascular defect and notably a cardiac septum defect were increased and statistically significant (OR=1.62, 95% CI 1.04-2.14, and RR 2.05, 95% CI 1.19-3.28, respective).”2
  • A study based on a review of Danish prescription register data reported a 2-fold increased risk of cardiac malformations with Zofran (ondansetron) use.3 An earlier review of the same prescription register that included fewer subjects, did not report an increased risk of major birth defects.4

GlaxoSmithKline Agrees to Pay Largest Health Care Fraud Settlement in U.S. History amid Allegations of Fraud and Failure to Report Safety Data

On July 2, 2012, The United States Department of Criminal Justice announced that GlaxoSmithKline “agreed to plead guilty and to pay $3 billion to resolve criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices…”

The civil settlement resolved claims brought by the United States alleging that GlaxoSmithKline promoted Zofran for the unapproved use for the treatment of morning sickness, and allegations that GlaxoSmithKline paid kickbacks to health care professionals to encourage them to promote and prescribe Zofran to pregnant women. The United States alleged that this conduct caused false claims to be submitted to federal health care programs.

MORE PROBLEMS FOR GLAXOSMITHKLINE – Promoting the unapproved or “off-label” use of Zofran for the treatment of morning sickness may have put expectant mothers and their unborn babies at risk for suffering Zofran side effects, and now GlaxoSmithKline faces personal injury lawsuits alleging that Zofran is responsible for multiple types of birth defects.

Obtain a Free Zofran Lawsuit Case Evaluation

If your child was born with a cleft palate, cleft lip, or heart defect that may be related to taking Zofran (ondansetron) during the early months of your pregnancy; and you would like to know more about your legal rights, please contact The Law Firm of Eric Weinberg for a free legal case evaluation. You can reach us toll free at 1-877-934-6274, or by submitting the easy-to-use “Free Legal Case Evaluation Form” found on this page.

References Cited:
1.) Anderka M. , Mitchell AA, Louikc, Werler MMA, Hernandez-diaz S, Rasmussen SA. National Birth Defects Prevention Study Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A 2012;94:22-30.
2.)Danielsson B, Wikner BN, Kallen B. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol 2014; 50:134
3.)Andersen JT, Jimmenez-Solem E, Andersen NL. Ondansetron use in early pregnancy and the risk of congenital malformations. Int Soc Pharmacoepidemiol2013. Abstract 25, Pregnancy session 1. Available at:
4.)Pasternak B, Svanstrom H, Hviid A. Ondansetron in pregnancy and risk of adverse fetal outcomes. N Engl J Med 2013; 368:814.

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Contact Weinberg Law Firm. You may also call us 24/7 at our toll free number, 1(877) 934-6274.