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Welcome To The Cleft Lip And Palate Foundation Of Smiles’ Zofran Information Center

ASK RACHELMy name is Rachel Mancuso and I am the founder of this wonderful community of parents.

You are likely on this page because you have seen one of our Facebook advertisements or posts about Zofran.

Zofran has been in the news lately because of lawsuits and lawyers filing child birth defect lawsuits. It has created a lot of confusion, anger, and worry.

Here at the Cleft Lip and Palate Foundation of Smiles we conducted our own investigation of all the facts, and as a result want to make sure the information consumed by OUR members is unbiased, and accurate. If a prescription drug is legitimately linked to causing a cleft lip and/or cleft palate, we want to make sure our members know about it, and know all the accurate facts.

If you have any questions about Zofran and the connection to cleft palate, please don’t hesitate to contact me in the “Ask Rachel” form below.

We are getting many inquiries from our members and this has prompted us to ensure we have all the resources at hand to handle any question you may have.

Again, welcome to our community. Feel free to get more involved via our Facebook page and our private Facebook group.

Yours faithfully,

Rachel Mancuso

Got Questions - ask rachel

About The Zofran Litigation

Zofran, a prescription drug manufactured by GlaxoSmithKline, is FDA approved for the prevention of severe forms of nausea and vomiting that often accompany chemotherapy, radiotherapy and surgical anesthesia.

The drug’s active ingredient is called ondansetron, and as many as 32 separate companies produce generic equivalents.

Zofran’s safety during pregnancy, or efficacy as a treatment for morning sickness, have never been studied. Neither the FDA, nor GlaxoSmithKline, have ever conducted clinical trials (studies using human subjects) to determine that the drug is free of harmful effects on fetal development.

Thus, it is not approved as a treatment for nausea and vomiting of pregnancy.

Download Our Zofran Studies Guide

Why Was Zofran Prescribed To Pregnant Women?

But America’s last drug to be FDA approved as a morning sickness treatment, Bendectin, was pulled from the market entirely in 1983. Bendectin’s recall, voluntarily issued by its manufacturer, came after numerous civil lawsuits alleged an association between Bendectin and birth defects. This recall left a large vacuum: around 6.7 million women become pregnant every year in the US, and upwards of 80% to 90% will experience morning sickness during the first trimester.

Morning sickness, especially in its most severe form, hyperemisis gravidarum, can be debilitating. And with few other options, physicians across the world began prescribing pregnant women Zofran to alleviate their symptoms of nausea and vomiting.

The practice of prescribing drugs for unapproved purposes, known as “off-label” prescription, is not regulated by the FDA, and physicians are free to prescribe any drugs they feel medically appropriate. But drug manufacturers are prohibited from marketing their products for any purposes other than those for which the FDA has found them “safe and effective.”

Department Of Justice Claims That GlaxoSmithKline Fraudulently Marketed Zofran

On July 2, 2012, the Department of Justice announced that GlaxoSmithKline had agreed to pay a settlement totaling $3 billion, in the largest single case of alleged health care fraud in US history.

Among the federal government’s claims were three criminal charges, including two counts of “introducing misbranded products […] into interstate commerce” and one count of “failing to report safety data […] to the Food and Drug Administration.” GlaxoSmithKline pled guilty to those three charges and paid a criminal fine of $1 billion.

But the DOJ’s allegations also included a number of civil violations. Two of the government’s claims involved Zofran:

1. The DOJ alleged that GlaxoSmithKline had “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”

2. The government also claimed that GlaxoSmithKline “paid kickbacks to health care professionals to induce them to promote and prescribe” Zofran.

While GSK continues to deny these allegations, the company agreed to pay $2 billion to resolve its civil liabilities.

Studies Begin To Establish Association Between Zofran & Birth Defects

At the same time, several large-scale research studies have come to troubling conclusions. In three major studies, scientific teams from around the world have found an increased risk of birth defects, including cleft palate, in babies born to women prescribed Zofran during the first trimester. You can find a summary of all studies performed on Zofran here.

Zofran’s Possible Link To Orofacial Clefts

Researchers at Harvard University and Boston University, funded in part by a grant from the US Centers for Disease Control & Prevention, reviewed the medical records of 10,383 women.

More than 67% of these women reported experiencing morning sickness, while 15.4% were prescribed a prescription drug for their symptoms. Comparing those women who had been prescribed Zofran or a generic equivalent to those who had not, the team found that babies exposed to ondansetron during early development were 2.37 times more likely to be born with cleft palate.

You can find an abstract of the study here.

Families Have Begun To File Lawsuits Against GlaxoSmithKline

Our research has found that several parents have filed private civil lawsuits against GlaxoSmithKline. In their complaints, these mothers and fathers claim that the company was aware of Zofran’s potential dangers during fetal development, but marketed the drug to pregnant women for an unapproved purpose anyway.

Specifically, a family from Montana filed a Zofran birth defect lawsuit on April 4, 2015, claiming that their daughter was born with a cleft lip and palate after her mother took Zofran as a morning sickness treatment during early pregnancy.

Read More About Other Drugs Connected To Cleft Palate


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Site last updated December 5, 2016 @ 3:07 pm; This content last updated July 9, 2015 @ 2:31 pm