35 Zofran Off Label Uses
Back to the zofran lawsuit. In most cases off label drug use provides more benefit than risk but it does occasionally cause problems.
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It is only approved to treat severe nausea and vomiting in patients undergoing chemotherapy radiotherapy and surgical anesthesia.
Zofran off label uses. This emedtv segment explains how ondansetron is used to prevent nausea and vomiting associated with several causes such as chemotherapy radiation and surgery. Zofran birth defects including cleft palate and congenital heart problems. An overview ondansetron hydrochloride zofran is a prescription medicine that has been licensed for preventing nausea and vomiting due to several causes.
It should be noted that at no time was this medication ever approved by the food and drug administration fda for off label use as required by federal law. Siskinds has learned that off label use of zofran carries a risk of birth defects when the medication is used during the first trimester of pregnancy. What is ondansetron used for.
Ondansetron is used off label to treat morning sickness and hyperemesis gravidarum of pregnancy. Ondansetron does have some off label uses such as to help prevent morning sickness during pregnancy. Allegedly gsk never even bothered doing any studies or clinical trials.
See full prescribing information for zofran tablets zofran odt and zofran oral solution. These highlights do not include all the information needed to use zofran tablets zofran odt and zofran oral solution safely and effectively. The zofran class action is an example of the dangers and consequences of off label drug use.
One of the most commonly prescribed off label treatments is zofran a drug with the active ingredient ondansetron. As ondansetron is prescribed off label in many countries it is important to accumulate a large cohort of patient outcomes to address its safe use in pregnancy including investigating the risks for specific birth defects. Zofran ondansetron hydrochloride tablets for oral use zofran odt ondansetron orally disintegrating tablets.
Problematic off label drug use. In the past large drug manufacturers have been fined by the justice department for intentionally marketing their drugs for off label use exposing patients and doctors to undue risk. It is typically used after trials if other drugs have failed.
This page also covers off label uses of ondansetron. There appears to be a low risk of harm to the baby with use during pregnancy though there may be an increase in heart problems among the babies.
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