Was Zofran recalled?
Was Zofran recalled?
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.
Is long term use of Zofran bad?
In rare cases, the drug can cause serious and potentially harmful side effects. These adverse reactions include long QT syndrome, a potentially deadly heart problem, and serotonin syndrome, a life-threatening combination of symptoms resulting from the overactive production of serotonin.
Has Zofran been discontinued?
The Food and Drug Administration (FDA) has posted a discontinuation notice for Zofran Oral Solution (ondansetron; Novartis).
Is Zofran still prescribed?
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.
Can Zofran be taken long term?
Effectiveness and safety of longer-term uses of ondansetron and granisetron have been investigated in randomized controlled trials (RCTs) enrolling patients with conditions other than nausea and vomiting, such as alcohol dependence, stable schizophrenia, and tinnitus. Treatment durations ranged from 4 to 12 weeks.
What is the history of the Zofran lawsuit?
The first Zofran lawsuit was filed in February 2015 by a Minnesota mother on behalf of her two daughters born with congenital heart defects. More families quickly followed suit, with actions piling up in federal courts in New Jersey, Texas, Alabama, Ohio, Montana, Louisiana, Arkansas, and Massachusetts.
Can I sue for birth defects caused by Zofran?
You could have a viable case if your child was born with birth defects after you (or your spouse) took Zofran while pregnant. Note that not all birth defects may be linked with Zofran. Some of the defects named in lawsuits that have already been filed include:
How much did GlaxoSmithKline pay for Zofran?
The Justice Department took the drugmaker to court in 2011, and GlaxoSmithKline agreed to pay the government $3 billion to settle the agency’s claims related to Zofran and other drugs. As of March 2019, this is still the largest settlement for alleged drug marketing violations in U.S. history.
Can you take Zofran while pregnant?
Given the effectiveness of the drug at treating those side effects, some doctors also began prescribing Zofran to pregnant women as an off-label treatment for morning sickness. Some women who took Zofran while pregnant later delivered babies with various birth defects.
