Zofran has proven to be an effective medication to treat nausea and vomiting, but the medication never gained approval for use in pregnant women. Despite the lack of approval, women battling morning sickness took Zofran, Zuplenz (similar drug) or ondansetron (generic version) which some families claim led to birth defects.
What is Zofran?
Zofran (ondansetron) and its spinoff Zuplenz are prescription medications that prevent or treat nausea and vomiting. They are types of medications called anti-emetics and belong to a class called 5HT3 receptor antagonists. The drugs work by blocking a neurotransmitter called serotonin in the areas of the brain that trigger nausea and vomiting. Zofran is manufactured and sold by GlaxoSmithKline. It was the first in its class on the market, and the U.S. Food and Drug Administration (FDA) approved it in 1991.
While Zofran, Zuplenz and the generic version (ondansetron) are only approved for use in treating nausea and vomiting after chemotherapy, radiotherapy or after surgery, doctors use them for off-label (unapproved) uses such as treating stomach problems in children and morning sickness in expectant mothers. About 80 percent of pregnant women experience nausea and vomiting during pregnancy (NVP). The most serious form of NVP, called hyperemesis gravidarum, can lead to malnutrition and dehydration dangerous for both the mother and the baby.