Zofran is the brand name for the generic medication ondansetron. Developed by British pharmaceutical company GlaxoSmithKline in the 1980s, the drug gained FDA approval in the United States in 1991.

Zofran was originally designed and marketed as a means of inhibiting the nausea, motion sickness and inevitable vomiting that occur in cancer patients after extensive chemotherapy and radiation therapy. As the drug’s significant effectiveness at preventing these symptoms has been continually verified, it is consequently the 20th best selling brand named drug in the United States.

Although the drug was originally designed and marketed for cancer patients, its effectiveness at hindering vomiting in cancer patients quickly found use among pregnant women.

Zofran Drug Classification

Although research has been conducted on the drug’s pediatric use, there has been no FDA approval regarding its safety toward unborn children. As such, the FDA has classified ondansetron under a “Class B” label. According to the FDA, a drug classified as “Class B” is one in which “animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.” Because it has been not been banned by the FDA for use among pregnant women, it is frequently used “off label” to treat the nausea and vomiting symptoms common during pregnancy, including morning sickness and hyperemesis gravidarum.

Zofran is an antiemetic. All antiemetics block vomiting or lessen feelings of nausea, and can be identified by the common suffix of their generic names: “-setron” (e.g., ondansetron). It operates as a serotonin 5-HT3 receptor antagonist. Certain biological or chemical factors can cause the release of serotonin in the lower intestine, which leads to vomiting. Zofran blocks the release of serotonin, thus preventing the feelings of nausea that lead to vomiting.

As with most modern pharmaceutical drugs, Zofran is not without its list of negative side effects. The most common Zofran side effects experienced among patients who use the drug are headaches, fatigue, constipation, diarrhea and dizziness. The frequency of these common Zofran side effects among patients changes depending on the length of time that the patient is using Zofran, and the total dosage taken. Patients using Zofran as a single-day application were more likely to experience headaches (~11-15%), and diarrhea (~3-7%). Long term clinical trials revealed a much longer list of reported side effects.

Zofran Reported Side Effects:

  • Perioperative and postoperative wound problems (28%)
  • Drowsiness/sedation (20%)
  • Headache (9%)
  • Hypoxia (9%)
  • Pyrexia (fever) (9%)
  • Dizziness (7%)
  • Gynecological disorder (7%)
  • Anxiety/agitation (6%)
  • Bradycardia (6%)
  • Shivers (5%)
  • Urinary retention (5%)
  • Hypotension (5%)
  • Pruritus (itch) (5%)

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Zofran Use During Pregnancy

While the overall operative Zofran side effects have been well studied, prenatal effects are not well known. However, recent studies are starting to indicate the strong possibility of certain Zofran birth defects. Both GlaxoSmithKline and the FDA have allowed for the drug’s use “off label” as an antiemetic for the nausea associated with pregnancy. GlaxoSmithKline specifically marketed Zofran for its “off label” potential as a morning sickness aid. Mounting evidence of Zofran birth defects led to a lawsuit against GlaxoSmithKline from the U.S. government, and an eventual Zofran  lawsuit settlement payment of $3 billion from the pharmaceutical company.

As individual lawsuits against GlaxoSmithKline continue to mount, more research into ondansetron on unborn children has resulted in a list of possible birth defects. While there are currently no reports of Zofran lawsuit settlements to individuals, there are nearly 200 pending lawsuits against GlaxoSmithKline for Zofran birth defects.

Zofran Reported Birth Defects:

The likelihood of any of these defects occurring as a result of using Zofran during pregnancy are currently not well known. However, Zofran has been verified as crossing the placenta, allowing it to be absorbed by the fetus much easier. Some studies suggest that use of Zofran doubles the risk of cleft lip and may increase the rate of any birth defect occurring by around 34%

Pregnant women who are concerned about Zofran birth defects, but still wish to treat morning sickness, can find alternative medications. Diclegis, the brand name for a pyridoxine/doxylamine combination drug, is available to pregnant women and has been found to be completely safe. It is classified as a “Class A” drug by the FDA. Clinical trials have yielded no results regarding birth defects. As such, the drug is safe to use without the risk currently associated with Zofran.

Due to the mounting evidence of Zofran birth defects, the FDA issued warnings about the possibility of problems with Zofran in 2011 and 2013. In 2012, GlaxoSmithKline issued a recall on all 32 mg intravenous doses of the drug, and has since ceased production of 32 mg doses. While there have been no new developments in research from the FDA or GlaxoSmithKline regarding the safety of Zofran, pending lawsuits are still in effect. GlaxoSmithKline has attempted to have all pending lawsuits dismissed, a motion that was denied by a federal judge in January of 2016.

See Frequently Asked Questions about Zofran.

If you were prescribed this medication while pregnant, our lawyers want to discuss your legal options with you and your family. Contact The Eichholz Law Firm at 1 (866) 947-7449 or fill out our free case evaluation form to get started.