Zofran May Result in Serious Fetal Injury


Zofran (Ondansetron) is manufactured by GlaxoSmithKline. The anti-nausea drug works by blocking the effects of serotonin, a natural substance which may cause nausea and vomiting.  Zofran was originally developed as a chemotherapy drug, and its use for morning sickness is considered “off-label”.  The manufacturer of Zofran, GlaxoSmithKline LLC, started a marketing campaign to get doctors to prescribe the drug for additional uses, like morning sickness.  Approximately 50% of women will experience morning sickness during their pregnancy, some pregnant women experience nausea and vomiting so severe that they will require medical intervention.   Countless babies have been put at risk for purely profitable reasons. GSK’s conduct has caused devastating, irreversible, and life-long consequences and suffering to innocent newborns and their families.


Studies Document Zofran a Risk of Fetal Outcomes

The FDA is investigating two side effects of this dangerous drug including serotonin syndrome and irregular heart rhythm that could lead to deadly cardiovascular events.

In addition, several studies have identified a link between Ondansetron, the active ingredient in Zofran, and an increased occurrence of congenital defects.

Since most women experience nausea and vomiting during the first trimester, they would be taking the drug at the same time the fetus is most vulnerable to developing malformations and deformities.

Studies suggest that babies exposed to Zofran in the first trimester of pregnancy are at an increased risk of a variety of birth defects, including (but not limited) to:

  • Cleft lip and cleft palate
  • Heart defects
  • Poor growth in the womb
  • kidney malformations
  • Jaundice
  • Serious pregnancy complications
  • Death
  • Skeletal defects

These defects can render an infant forever dependent on their parents for care, resulting in enormous medical costs, mental anguish, and emotional distress.


Lawsuits and Claims Against GlaxoSmithKline, Zofran’s Manufacturer

In 1992, GlaxoSmithKline was aware that Zofran passes from mother to fetus through the placenta, presenting a risk of harm to developing infants. Despite this knowledge, the drugmaker continued to market Zofran to pregnant women, making an exuberant profit in the process.

GSK has committed multiple actions which constitute negligence and can be grounds for a lawsuit. Among them:

  • They failed to ensure the drug’s safety and determine its risks before selling it to the public.
  • They failed to warn the public about dangerous side effects.
  • They marketed the drug as a safe treatment for morning sickness in pregnant women even if it was not approved by the FDA for this use.
  • They produced a defective drug.

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.


At Oliver-Zhang Law, our Attorneys are here to inform and assure all pregnant women are fully aware of  the risks of Zofran. Our experienced Attorneys in Pharmaceutical liability cases, are currently handling Zofran lawsuits nationwide, providing confidential and free consultation.  If you or a loved one took Zofran during pregnancy giving birth to a child with birth defects? please call us to review the details of your case to see if you qualify for compensation.