Zofran (ondansetron) is an antiemetic drug, used to treat and prevent nausea and vomiting. It was the first in a class of drugs called serotonin-3 (5-HT3) receptor antagonists to receive meant to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. It is not and never has been approved for use in pregnant women, but for many years it was prescribed off-label to treat nausea and vomiting of pregnancy (NVP).
Zofran was approved by the U.S. Food and Drug Administration (FDA) in 1991. It is approved for the following uses:
- Prevent nausea and vomiting caused by chemotherapy treatment for cancer
- Prevent nausea and vomiting caused by radiation therapy
- Prevent post-surgical nausea and vomiting
Zofran Side Effects
The following side effects have been associated with Zofran use:
- Serotonin syndrome
- QT prolongation
- Blurred vision
- Temporary vision loss
- Severe dizziness
- Shortness of breath
- Difficulty breathing
- Fast or pounding heartbeats
- Slow heart rate
- Urinating less than usual or not at all
Serotonin syndrome occurs when high levels of serotonin accumulate in your body. It is a medical emergency and can be life-threatening.
QT prolongation is an electrical disturbance in the heart that can cause serious irregular heart rhythms. It can be fatal.
The FDA only approves drugs for specific purposes. When a drug is used for any other purpose, it is referred to as “off-label”. Doctors are allowed to prescribe drugs off-label, when they feel it is in the best interests of their patients. Drug companies, on the other hand, are not allowed to market their products for off-label purposes.
Zofran is sometimes prescribed off-label to treat acute gastroenteritis in children.
For many years, Zofran was also prescribed off-label to treat morning sickness in pregnant women. In 2012, the manufacturer reached a settlement agreement with the government regarding the marketing of several pharmaceutical products. There were no findings that the manufacturer illegally marketed Zofran and the manufacturer did not admit wrongdoing or agree to plead guilty with respect to the marketing of Zofran.
Dangers of Zofran Use in Pregnancy
Zofran use during pregnancy can cause harm to the fetus and birth defects including:
- Fetal death
- Fetal growth restriction
- Congenital heart malformations
- Heart murmurs
- Orofacial clefts
- Skeletal abnormalities
- Skull deformities
- Kidney malformation
- Clubbed foot
- Vision problems
- Hearing loss
If you have questions about Zofran that are not answered here or believe your child’s birth defect was caused by Zofran, please email us or call us toll-free at 800-DRUG-411 (800-378-4411). We will help you find answers to your questions and we can refer you to an attorney who represents families of children with birth defects.