Zofran was introduced in the 1990s to treat nausea associated with radiation-based cancer therapies. Shortly thereafter, doctors began prescribing the drug to pregnant women to treat morning sickness.
Hundreds of women have taken legal action against drugmaker GSK, alleging that the company knew about Zofran’s birth defect risks.
But Zofran was never safety tested or approved for this use. Unfortunately, several studies have demonstrated a link between Zofran and birth defects.
Hundreds of women are now taking legal action against drugmaker GlaxoSmithKline (GSK), alleging that while the company knew about birth defect risks, it never warned consumers as it continued to promote the drug for pregnant women.
Research Links Zofran to Birth Defects
A number of studies have made the connection between Zofran and congenital defects.
One of the first studies, published by BJOG: An International Journal of Obstetrics & Gynaecology in 2004, observed miscarriages and malformations among infants exposed in the womb to ondansetron, but the study was hampered by a small sample size.
A 2012 study found an association between first trimester use of ondansetron (Zofran) and craniofacial defects. The following year, a review of Danish data found an increase in the prevalence of major congenital heart defects in children of women prescribed Zofran during the first trimester.
A Toronto Star investigation of birth defects reported by Canadian mothers to the U.S. Food and Drug Administration (FDA) details 20 women who were prescribed Zofran for vomiting in pregnancy and delivered children with defects like heart and kidney problems.
Research has shown that, when taken by pregnant mothers, Zofran can pass on to the developing fetus. One study concluded that “a significant amount of ondansetron” was detected in neonates, and that the drug had a longer half-life in neonates than their mothers.
Defects Associated with Zofran
Zofran may cause the following types of major birth defects:
- Heart defects, including septal defects or holes in the heart
- Craniofacial defects, including cleft palates
- Kidney malformations
Zofran Not Approved for Morning Sickness Symptoms
The only FDA-approved use of Zofran is for nausea and vomiting associated with cancer treatments like chemotherapy and radiation.
Roughly 10-15% of pregnant women are prescribed a drug for nausea. Incredibly, nearly 98% of the medications prescribed for this use are not labeled for use in pregnancy. These drugs, which include Zofran, are not classified as safe during pregnancy by the FDA.
In the 2000s, Zofran became the most-prescribed drug for morning sickness in the U.S. From 2008 to 2013, monthly ondansetron prescriptions for morning sickness ranged from 50,000 to 110,000 per month.
Feds Fine GSK for Off-Label Zofran Promotion
It is not illegal for doctors to prescribe drugs for off-label uses (uses for which they are not FDA-approved), but it is illegal for drug companies to promote off-label uses of their products.
In 2012, the Justice Department fined GlaxoSmithKline $3 billion for unlawful promotion of Zofran and other drugs. GSK was also fined for failing to report safety data, and for false price reporting practices.
According to the Justice Department, GSK:
- Promoted Zofran for unapproved uses, including pregnancy-related nausea.
- Made false and/or unsubstantiated representations about the use of Zofran for pregnancy-related nausea.
- Paid illegal kickbacks to healthcare professionals to promote Zofran.
The federal government alleges that these practices took place from January 2002 to December 2004. Years prior, in 1999, GSK had received a written warning from the FDA for promoting Zofran “in a manner that is false or misleading because it lacks fair balance.”
Over 15 years ago, the FDA ordered GSK to cease such promotions immediately. Unfortunately for hundreds of women and their children, GSK didn’t listen.
Canadian Labels Warn Against Use by Pregnant Women
Making the case against GSK even stronger: since April 2015, Canadian Zofran labels say that “the safety of ondansetron for use in human pregnancy has not been established,” and that “use in pregnancy is not recommended.”
Conversely, the U.S. label reads:
Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It’s unfathomable why GSK would include an adequate label on its Canadian Zofran but not the American one. Regardless, they have acknowledged (in Canada, at least) the risks inherent in taking Zofran while pregnant, which makes them even more vulnerable to litigation.
Hundreds of women have taken legal action against GSK, alleging that Zofran caused their children to develop congenital defects.
The lawsuits allege that GSK promoted Zofran off-label for morning sickness despite never establishing the safety of the drug for this use.
The lawsuits also allege that GSK promoted Zofran off-label for morning sickness despite never establishing the safety of the drug for this use in a single clinical study. Plaintiffs allege that, lacking sufficient safety data, they had no way of knowing whether Zofran was a safe and effective treatment for morning sickness. Many women say that, had they known of the birth defect risks, they never would have taken the drug.
Plaintiffs further argue that GSK knew as early as the 1980s that Zofran was potentially toxic to unborn babies. They say that GSK began receiving Zofran birth defect reports in the early 1990s but never disclosed this information to the public, even as it began to market the drug to pregnant women.
Zofran Mass Tort Lawsuit
Women from all corners of the United States have filed Zofran birth defect lawsuits. To help with pretrial evidence gathering and other procedures common to these lawsuits, all Zofran cases have been centralized in a Massachusetts District Court as part of a multi-district litigation (MDL, or mass tort).
A mass tort allows each plaintiff to maintain their own lawyer and their own lawsuit. As of today, the Zofran MDL contains more than 230 claims—a number that is expected to grow as more mothers learn about Zofran birth defects and file lawsuits.
Are You Suffering from Severe Side Effects?
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