Cancer Home > Zuplenz and Pregnancy
When pregnant animals were given high doses of the active ingredient in Zuplenz (ondansetron oral soluble film), it did not appear to cause any problems. Therefore, the FDA classifies it as a pregnancy Category B medication. However, the full risks of taking this medication during pregnancy are unknown, and it should only be prescribed if the benefits outweigh the possible risks.
Can I Take Zuplenz When Pregnant?Zuplenz™ (Ondansetron Oral Soluble Film) is generally considered safe for use during pregnancy. This is based on animal studies that looked at the effects of the drug during pregnancy.
What Is Pregnancy Category B?The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
Also, medications that have been shown to be safe for use in pregnancy in humans, but have caused problems in laboratory animals are also given a Category B rating.
In studies, giving pregnant rats and rabbits high doses of ondansetron (the active ingredient in Zuplenz) did not cause any problems. These studies used dosages that were up to 30 times the equivalent dosage normally used in humans.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.