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About Zofran

woman holding her own pregnant bellyFirst receiving approval by the U.S. Food and Drug Administration (FDA) in 1991, ondansetron (known to most as Zofran) is a drug designed to treat nausea and vomiting in surgical and chemotherapy patients. Known as a 5-HT3 antagonist, it works by acting on the human nervous system to block serotonin and facilitate gastric emptying.

In addition to the aforementioned uses, some doctors prescribe Zofran to pregnant women suffering from the effects of severe morning sickness, also known as hyperemesis gravidarum. Because the drug has not been approved for use by pregnant women, this application is referred to as being “off-label.”

Concerns have begun to arise about a link between the use of Zofran by expectant women and an increased risk for serious birth defects, including those affecting the heart, the kidneys, and facial deformity.

Key facts about Zofran and its uses

Morning sickness, or vomiting and nausea during pregnancy, is experienced by a significant number of expecting mothers. Hyperemesis gravidarum is a particularly intense form of the affliction and can involve nutritional loss, dangerous dehydration, muscle wasting, hospitalization and loss of over 5% of pre-pregnancy body weight. Clearly, these effects pose very real dangers to both mother and baby. As a result, many women who are experiencing debilitating morning sickness turn to drugs such as Zofran to maintain their everyday functionality and prevent the development of complications that could impact their fetus.

This use of Zofran to treat pregnant women has never received FDA approval and there is a distinct lack of research on the safety of the practice. The drug is currently classified as a “Category B” medication, meaning that animal studies have failed to establish a risk to fetuses, but that no sufficient, properly-controlled studies have been conducted to conclusively demonstrate the drug’s safety for pregnant women. Meanwhile, allegations have been raised that birth defects may be a side effect of Zofran when the medication is used during pregnancy.

Studies raise concerns about Zofran and birth defects

Growing concern about the off-label use of Zofran in pregnant women yielded multiple studies exploring a possible link between the medication and birth defects. A 2013 study presented in the New England Journal of Medicine found no support for allegations of a connection between Zofran and heart defects. The study analyzed data culled from the Danish Medical Birth Registry and assessed birth outcomes of expectant mothers who were given Zofran during their pregnancies occurring between the years of 2004 and 2011. However, the average gestational age of the fetuses thus exposed to the drug was 10 weeks, a point at which most babies are no longer in danger of developing serious defects.

Several months later a study was conducted by a different group of researchers who used the same Danish birth registry to extract data, but examined much more information spanning a broader period of time. Roughly 900,000 births occurring from 1997-2010 provided the basis for the final conclusions. The authors of this second study found that Zofran was associated with a 30% overall increase in birth defects. Of the women studied, 1,368 had filled a Zofran prescription during their first trimester, with 61 (4.7%) of them ultimately giving birth to babies with congenital malformations. This stands in comparison to an occurrence of defects in just 3.5% of the group of mothers unexposed to Zofran.

Scientific research has investigated the potential link between Zofran and birth defects such as:

  • Atrial septal defects in the heart
  • Heart murmur
  • Neural tube defects
  • Cleft palate
  • Kidney defects
  • Fetal growth restriction in the womb
  • Jaundice
  • Skull deformities
  • Fetal death

Zofran lawsuits emerge

Pregnant women who took Zofran believed it was a safe and effective way to manage severe morning sickness. Now that concerns are being raised about potential fetal injury risks, consumer advocates and attorneys are taking notice.

Plaintiffs in Zofran lawsuits allege that GlaxoSmithKline (GSK), the maker of Zofran, had knowledge of the drug’s unreasonable risk of harm to unborn babies as far back as 1992, but continued to urge doctors to prescribe it for off-label applications. Lawsuits also allege that GSK made misrepresentations to physicians and hospitals regarding the safety of the drug for pregnant women.

Families are suing on causes of action such as:

  • Strict products liability
  • Negligence
  • Fraudulent concealment
  • Breach of warranties
  • Deceptive trade practices
  • Negligent misrepresentation of research studies

In 2012, GlaxoSmithKline, maker of Zofran, agreed to pay $3 billion to resolve criminal and civil charges of illegal promotion of multiple drugs, failure to report safety data and false price reporting actions. In announcing the civil portion of the settlement under the False Claims Act, the Department of Justice specifically mentioned GSK’s promotion of Zofran, a drug only approved for use in post-operative patients and those undergoing chemotherapy, for the treatment of morning sickness. At the time, the $3 billion resolution comprised the largest health care fraud settlement ever in the United States, and biggest payout ever by a pharmaceutical company, according to the Department of Justice.

Despite the settlement, GSK did not admit to any civil liability or wrongdoing in regard to Zofran or any of its other pharmaceutical products.

Size and scope of Zofran litigation yet to be determined

While no Zofran lawsuits have reached trial stage and no settlements have been announced, Zofran lawyers across the country are currently reviewing potential claims on behalf of mothers who believe their babies suffered harm because of the medication.

Plaintiffs in Zofran litigation seek to recover damages for:

  • Current, past and future medical bills
  • Pain and suffering
  • Emotional trauma
  • Lost wages/earning capacity
  • Costs of rehabilitation services

It will be necessary for lawyers to demonstrate that GSK manufactured and marketed drugs that were indeed dangerous to the public, were promoted without sufficient warning of known dangers, and presented as being a safe method of treating hyperemesis, despite the drug never having received FDA approval for that use.

Zofran attorneys will need to marshal substantial research and testimony from medical experts in order to prevail. In addition to securing fair financial compensation for those allegedly harmed by the off-label use of Zofran, these product liability lawsuits may seek punitive damages to provide a deterrent to negligent behavior by drug companies in the future.

  1. Toronto Star, Birth defects blamed on unapproved morning sickness treatment,
  2. United States Department of Justice, GlaxoSmithKline to Plead Guilty and Pay$3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,
  3. U.S. Food and Drug Administration, Ondansetron (marketed as Zofran) Information, PatientsandProviders/ucm271924.htm
  4. Motherisk, Ondansetron Use In Early Pregnancy And The Risk Of Congenital Malformations - A Register Based Nationwide Cohort Study,