Is Zofran being taken off the market?
The 32-mg, single intravenous dose of Zofran (ondansetron), an anti-nausea drug, is being removed from the market due to its potential to cause serious, even fatal, cardiac damage, according to a Drug Safety Communication issued Dec. 4 by the U.S. Food and Drug Administration.
Why was Zofran discontinued?
FDA Drug Safety Communications & Zofran Recall In 2012, the 32 mg intravenous dose of Zofran was pulled from the market due to concerns that it could trigger QT interval prolongation, a heart rhythm disorder that could lead to an abnormal and potentially fatal heart rhythm called Torsades de Pointes.
Do doctors still prescribe Zofran?
It was originally used to treat nausea associated with chemotherapy or surgery. It’s still used and approved by the Food and Drug Administration (FDA) for this purpose. But now, Zofran has also become a frequently prescribed drug to reduce nausea and vomiting in pregnancy.
Why is ondansetron restricted?
Ondansetron (Zofran): important new intravenous dose restriction. New maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) restricted due to risk of QTc prolongation.
Is Zofran a narcotic?
Is Zofran (ondansetron) a narcotic? No, Zofran (ondansetron) is not a narcotic, instead it belongs to a class of medication called 5-HT3 (serotonin) receptor antagonist.
What class of drug is Zofran?
5-HT3 antagonist
Ondansetron/Classification
What is similar to Zofran over the counter?
Dramamine is available over-the-counter (OTC). Ondansetron and Dramamine belong to different drug classes. Ondansetron is a serotonin-3 (5-HT3) receptor antagonist, and Dramamine is an antihistamine. Side effects of ondansetron and Dramamine that are similar include drowsiness and constipation.
Is Bonjesta a Zofran?
Zofran and Bonjesta belong to different drug classes. Zofran is an antiemetic (anti-nausea and vomiting) and selective 5-HT3 receptor antagonist and Bonjesta is a combination of an antihistamine and a Vitamin B6 analog.
Is ondansetron a narcotic?
What class of drug is ondansetron?
Does Zofran make you loopy?
Headache, lightheadedness, dizziness, drowsiness, tiredness, or constipation may occur. If these effects persist or worsen, notify your doctor promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.
Is Zofran considered a narcotic?
Why are there so many lawsuits about Zofran?
As the result of babies being born with birth defects after their mothers were prescribed Zofran, hundreds of lawsuits have been filed in 2017 and before, claiming the manufacturer fraudulently promoted the drug for pregnant women.
When did glaxosmithkile get approval for Zofran?
In 1991, GlaxoSmithKile’s anti-nausea drug Zofran (ondansetron) received approval from the U.S. Food and Drug Administration (FDA) to manage nausea and vomiting side effects of cancer treatments like chemotherapy, radiation and surgery.
Are there any birth defects associated with Zofran?
Zofran lawsuits claim the manufacturer failed to warn patients of the possibility of birth defects associated with the anti-nausea drug. More than 670 Zofran lawsuits have been filed by mothers whose babies suffered birth defects like cleft palates, kidney malformations, skull deformities and heart defects.
What is the generic name for Zofran for?
Zofran, whose generic name is ondansetron, was FDA approved to treat nausea and vomiting in cancer patients undergoing chemotherapy or radiation treatments and after surgeries for people who reacted badly to anesthesia.