Zofran (ondansetron) is a powerful anti-emetic drug developed and manufactured by British company GlaxoSmithKline. The Food and Drug Administration (FDA) approved it in 1992 for the prevention of nausea and vomiting associated with cytotoxic treatment protocols such as radiation therapy and chemotherapy, as well as that associated after surgery.
It is important to control severe nausea and vomiting in patients because it can lead to dangerous levels of dehydration and electrolyte imbalance. There are some conditions where Zofran, which is a very powerful drug, is the only solution.
However, according to the website of Williams Kherkher, there are instances that Zofran can do more harm than good. Popular off-label uses for Zofran is for nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum, cyclic vomiting syndrome, and gastroenteritis. These are considered “off-label” because the FDA has not approved it for those conditions. In most cases, there are no unexpected and serious side effects, so everybody is happy. That is not true in pregnant women.
There is good reason to believe that Zofran can increase the risk of adverse fetal outcomes when prescribed to women during their first trimester. Earlier studies did not indicate this, but further research brings its safety into question.
The studies are far from conclusive, and in some cases flatly contradict each in the most ironic ways, but the fact remains that the risks are just not known. Considering the extent of harm that can be done to the developing fetus, it is recommended that pregnant women use alternative drugs to Zofran that have been proven safe for pregnant women. It is better to err on the side of caution when protecting the children from harm.
If you have first-hand knowledge about the dangers of Zofran, consider filing a lawsuit against the manufacturer. Consult with a personal injury lawyer specializing in Zofran in your area and discuss your case. This will help you clarify your legal options.