What is Zofran?

Zofran is the trade name of ondansetron, a drug approved by the US FDA to prevent nausea and vomiting in certain extreme situations, such as:

  • following cancer chemotherapy
  • following radiation therapy
  • after surgery[1]

It is also occasionally used in emergency room settings to control vomiting from severe gastroenteritis.[2]

Zofran is also commonly prescribed to pregnant women experiencing the nausea and vomiting associated with morning sickness. Though this use has never been approved by the FDA, doctors frequently recommend the drug ‘off-label,’ due to the manufacturer’s claims that the drug has never been proven to be unsafe for use by pregnant women. As evidence surfaces linking birth defects and other serious health complications with use of the drug, families have begun to bring lawsuits against manufacturer GlaxoSmithKline (GSK).

The first drug of its kind approved for use in the US, Zofran is believed to function by blocking serotonin receptors in the nerves of the gastrointestinal tract and in the area of the brain that controls vomiting.[3] It can be administered in these forms:

  • injection
  • premixed injection
  • oral tablets (4 mg, 8 mg, and 24 mg)
  • orally disintegrating tablets (4 mg and 8 mg)
  • oral solution

An additional form – 32 mg intravenous (IV) dose – was pulled from the market by the FDA in 2012, after it was found to pose potentially fatal cardiac risks.[4]

What is GlaxoSmithKline?

Zofran is manufactured and marketed by GlaxoSmithKline (GSK), a multinational pharmaceutical company headquartered in London. It is the world’s sixth-largest pharmaceutical company, with a market capitalization of £73 billion (US$113.7 billion), the fourth-largest of any company on the London Stock Exchange.

GSK has offices in over 115 countries and employs nearly 100,000 people. They sell their products in 170 countries, with the largest market being the US. In 2011, sales reached $44 billion , and in 2013, the company spent $3,720,000 on federal lobbying efforts in the US.

GSK developed Zofran in the mid-1980s, and received approval to market the drug in the US by the FDA in 1991. By 2006, the final year of its patent, Zofran was the 20th highest-selling brand-name drug in the US, generating $1.3 billion for the company in just nine months (80% of that from US markets).

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Complications & Side Effects of Zofran

However, the huge profits generated by the sell of Zofran wasn’t merely for FDA-approved uses. There is evidence that GSK encouraged doctors to prescribe Zofran to pregnant women for the “off-label” use of treating nausea and vomiting associated with pregnancy (NVP). About 80% of pregnant women experience this illness, often referred to as morning sickness. In its most dangerous form, it is called hyperemesis gravidarum and can result in malnutrition, endangering the mother and the unborn child.

Noting the eagerness of doctors to prescribe Zofran to pregnant women, Dr. G. Koren raised the alarm in 2014:

“The use of ondansetron [the generic term for Zofran] for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias.”

Koren concluded that out of 4 million pregnancies in the US every year, about 1 million pregnant women will be exposed to Zofran or its generic equivalent.


The reason many medical professionals are trying to curb or stop the use of this drug by pregnant women is that Zofran easily crosses the placental barrier, exposing the unborn child to the drug. GSK was aware of the drug’s mobility across the placenta since at least the 1980s, through its preclinical trials, but still promoted itself as a safe option for pregnant women.

Now scientific research is finding an increase of serious birth defects in babies born to mothers who took Zofran on their doctor’s orders. In 2013, a massive study of 900,000 pregnant women found a 20% increase of major birth defects for those mothers who took Zofran or its generic equivalent (ondansetron) in their first trimester of pregnancy. After exposure, it was found, babies had a 2-4-fold greater risk of “hole in the heart” defects, including:

  • 2.1 times more likely to have atrial septal defects
  • 2.3 times more likely to have ventricular septal defects
  • 4.8 times more likely to have atrioventricular septal defects

Research published in December of 2014 reiterated this risk, finding that mothers who took Zofran had a 62% increased risk in giving birth to a baby with a cardiovascular defect. Other research links Zofran to an increased risk of cleft palate, showing that mothers who took the drug in their first trimester birthed twice as many babies with the facial defect.

Results like these have pushed pediatricians and gynecologists to warn that prescribing the drug as a first-line option to pregnant women is a violation of professional and science-based standards.

  • Heart Defects
  • Club foot
  • Skull deformities
  • Hearing loss
  • Vision problems
  • Abnormal blood pressure
  • Stomach problems
  • Mental problems
  • Webbed toes
  • Physical deformities

Lawsuits against GSK

Families who have been affected by this potential link between Zofran and the above disabilities are beginning to come forward in lawsuits against GlaxoSmithKline, claiming that the company made massive amounts of money by promoting a drug to a population who was harmed by it.

As stated in one of the lawsuits being brought against GSK:

In summary, since at least 1992, GSK has had mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy. [. . .] GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women.[1]

Three years ago, the US Government brought criminal charges of fraud against GSK, for promoting unapproved uses for its drugs and failing to report crucial safety data. One of these drugs was Zofran. The Department of Justice alleged that GSK knowingly:

  • “promoted the sale and use of Zofran for a variety of conditions other than those for which it was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea).”
  • “made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran” for morning sickness.
  • “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran, in violation of the Federal Anti-Kickback Statute.”[2]


Following the settlement, Bill Corr, Deputy Secretary of the Department of Health and Human Services (HHS) said:

For a long time, our health care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing.[3]

But for many families, the equation is not changing rapidly enough, as they continue to live with the toxic legacy of pharmaceutical greed. That is why families are beginning to file lawsuits against GSK.

In Alabama, Julie Hunter has filed a lawsuit against the company along with her son, who was born with facial deformities, extra digits, glaucoma, distended kidney, and a ureteral disorder, after she took Zofran in her first trimester of pregnancy on her doctor’s orders. Her son’s seizures started when he was 9 months old. He is still nonverbal and has delayed reactions. Doctors have ruled out the possibility that he inherited these disabilities from his parents.[4]

A similar lawsuit was recently brought by Cheri Flynn in Pennsylvania, who used Zofran in the first trimester of two pregnancies, with resulting birth defects in her two children. The first child had a hole in the heart, and was forced to undergo heart surgery in 2011. The second baby was born prematurely and suffers significant developmental delays, including being unable to breathe adequately. Flynn claims marketing drug like Zofran as safe is “tantamount to using expectant mothers and their unborn children as human guinea pigs.”[5]

Other lawsuits have been filed around the country in the last several months alone, and that number is expected to climb as families seek justice for the damage done to them and their loved ones.

[1]    FDA Prescribing Information Label for Zofran (ondansetron hydrochloride). www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf

[2]   Freedman, Stephen B. et al. “Oral Ondansetron for Gastroenteritis in a Pediatric Emergency Department” The New England Journal of Medicine, 354:1698-1705 (April 20, 2006) http://www.nejm.org/doi/full/10.1056/NEJMoa055119

[3]   FDA Prescribing Information Label for Zofran (ondansetron hydrochloride). www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf

[4]   FDA Drug Safety Communication: “Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mised ondansetron products.” (Dec 4, 2012) http://www.fda.gov/Drugs/DrugSafety/ucm330049.htm

[5]   FTSE All-Share Index Ranking (unofficial guide). (May 1, 2015). http://www.stockchallenge.co.uk/ftse.php

[6]   GSK Annual Report 2013. http://www.gsk.com/media/325156/annual-report-2013.pdf

[7]   GSK Annual Report 2013. Pg 47. http://www.gsk.com/media/325170/cr-report-2013.pdf

[8]   “Generics Firms Line Up to Enter Zofran Market.” IHS. (Dec 28, 2006). https://www.ihs.com/country-industry-forecasting.html?id=106598562

[9]   “Hyperemesis Gravidarum: Signs, Symptoms, and Treatment. American Pregnancy Association. http://americanpregnancy.org/pregnancy-complications/hyperemesis-gravidarum/

[10]   Koren, Gideon, MD, FRCPC, FACMT, FAACT. “Treating Morning Sickness in the United States – Changes in Prescribing are Needed.” American Journal of Obstetrics and Gynecology. 211(6)602-6 (Dec 2014). http://www.ajog.org/article/S0002-9378%2814%2900853-9/fulltext

[11]   Siu, SS, Chan, MT, and Lau, TK. “Placental transfer of ondansetron during early human pregnancy” Clinical Pharmacokinetics 45(4):419-23 (2006). http://www.ncbi.nlm.nih.gov/pubmed/16584287

[12]   FLYNN v. GLAXOSMITHKLINE LLC (2:15-cv-00709), Pennsylvania Eastern District Court. Pg 8. http://www.google.com/url?q=http%3A%2F%2Fwww.aboutlawsuits.com%2Fwp-content%2Fuploads%2F2015-02-12-Flynn-Complaint.pdf&sa=D&sntz=1&usg=AFQjCNGRqurw4N1C6_uoJHIP8V3aI4KkyQ

[13]   Anderson, Jon T. MD, PhD, et al. “Ondansetron use in Early Pregnancy and the Risk of Congenital Malformations – A Register Based Nationwide Cohort Study.” Presented to the International Society of Pharmaco-epidemiology, Montreal, Canada (2013). http://www.motherisk.org/documents/studies/Ondansetron-Use-In-Early-Pregnancy.pdf

[14]   Danielsson, B, Wikner, BN; Kallen B. “Use of Ondansetron During Pregnancy and Congenital Malformations in the Infant” Reproductive Toxicology 50:134-7 (Dec 2014). http://www.ncbi.nlm.nih.gov/pubmed/25450422

[15]   Anderka M, et al. “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects.” Birth Defects Research Part A: Clinical and Molecular Teratology 94(1):22-30 (Jan 2012). http://www.ncbi.nlm.nih.gov/pubmed/22102545

[16]   Koren, Gideon, MD, FRCPC, FACMT, FAACT. “Treating Morning Sickness in the United States – Changes in Prescribing are Needed.” American Journal of Obstetrics and Gynecology. 211(6)602-6 (Dec 2014). http://www.ajog.org/article/S0002-9378%2814%2900853-9/fulltext

[17]   Product Monograph for Zophran. March 1, 2010. Pg. 5. http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB8QFjAA&url=http%3A%2F%2Fwww.gsk.ca%2Fenglish%2Fdocs-pdf%2FZofran_2010.pdf&ei=VjJVVYTjC8SHyASQmIDYAg&usg=AFQjCNFZR7pLrvxavh3aTVxdZ8OnhnyiTA&sig2=QHxBqOCVzN3sh65vtuOEiQ&bvm=bv.93564037,d.aWw

[18]   FLYNN v. GLAXOSMITHKLINE LLC (2:15-cv-00709), Pennsylvania Eastern District Court. Pg. 32.   http://www.google.com/url?q=http%3A%2F%2Fwww.aboutlawsuits.com%2Fwp-content%2Fuploads%2F2015-02-12-Flynn-Complaint.pdf&sa=D&sntz=1&usg=AFQjCNGRqurw4N1C6_uoJHIP8V3aI4KkyQ

[19]   Settlement Agreement, United States v. GlaxoSmithKline. 2012. www.justice.gov/sites/default/files/opa/legacy/2012/07/02/plea-ex-b.pdf

[20]   United States Department of Justice. Press Release: “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data.” July 2, 2012. http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

[21]   Julie Hunter v. GlaxoSmithKline, LLC. US District Court of Alabama. Case 2:15-cv-00544-JEO. April 2015. http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CCcQFjAB&url=http%3A%2F%2Fwww.aboutlawsuits.com%2Fwp-content%2Fuploads%2F2015-04-01-Hunter-Complaint.pdf&ei=T5pKVcflF4afsAXMk4G4DQ&usg=AFQjCNH3sj7qz9e4CKtNmBsJmoAp88_9FA&sig2=RzTbGxsMwVV8Avn7ctQ89w&bvm=bv.92765956,d.b2w

[22]          FLYNN v. GLAXOSMITHKLINE LLC (2:15-cv-00709), Pennsylvania Eastern District Court.   http://www.google.com/url?q=http%3A%2F%2Fwww.aboutlawsuits.com%2Fwp-content%2Fuploads%2F2015-02-12-Flynn-Complaint.pdf&sa=D&sntz=1&usg=AFQjCNGRqurw4N1C6_uoJHIP8V3aI4KkyQ