Developed in the late 1980s by pharmaceutical giant GlaxoSmithKline, Zofran is a potent anti-nausea drug. This medication, also known by its generic name ondansetron, has been FDA-approved for specific uses since 1991.
Based on clinical studies demonstrating Zofran’s safety, the FDA approved ondansetron for the treatment of nausea in cancer patients recovering from chemotherapy and radiation treatments. Later, Zofran’s approval was extended to cover certain forms of nausea that occur after surgery.
Severe Health Risks Of Zofran: Research & Results
Zofran has never been approved for the treatment of morning sickness in pregnant women. In fact, its effects have never even been studied for morning sickness in expectant mothers or their developing babies.
But a lawsuit brought by the US Department of Justice alleged, this lack of medical evidence didn’t stop GlaxoSmithKline from marketing Zofran to obstetricians and gynecologists as a safe treatment for severe morning sickness. While prescribing medications for unapproved, “off-label” purposes is not illegal, marketing them for these uses is against the law.
In 2012, GlaxoSmithKline settled with the Department of Justice for $3 billion. But a slew of scientific research, along with seven recently-filed personal injury lawsuits, suggests that only a fraction of the damage caused by GlaxoSmithKline’s allegedly unlawful practices has come to light.
Reports of children born with serious birth defects have begun to surface, and research teams across the globe are hurrying to examine ondansetron’s link to tragic conditions like cleft palate and congenital heart defects. In the meantime, women and children who have been affected by GlaxoSmithKline’s allegedly fraudulent marketing may be entitled to considerable compensation.
On this page, you’ll find summaries of key studies that have investigated the association between Zofran and birth defects.
Numerous Studies Have Shown The Dangers Of Zofran
Medications Used To Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects
Funded by the US Centers for Disease Control & Prevention, a team of researchers at Harvard and Boston University’s Slone Epidemiology Center looked at two groups of new mothers. The first, a sample of 4,524 women, had all delivered children with major birth defects. The second, 5,859 women, had given birth to healthy babies. 67.1% of the women in both groups reported experiencing nausea and vomiting during the first trimester of pregnancy; 15.4% said they had been prescribed medication to reduce the symptoms.
Comparing both groups, the researchers found an increased risk of birth defects after exposure to Zofran or a generic form of ondansetron. In all, pregnant women who took ondansetron were 2.37 times more likely to deliver a baby with a cleft palate.
To learn more about cleft palates, lips and GlaxoSmithKline’s potential liability for child birth defects, click here.
Off-Label Use of Ondansetron in Pregnancy in Western Australia
Researchers from the University of Western Australia reviewed every birth record maintained for women in Western Australia between 2002 and 2005. In total, 96,968 women delivered babies, while only 251 had been prescribed ondansetron to treat severe morning sickness.
The study found that pregnant women who had taken ondansetron were 20% more likely to deliver babies with major birth defects, but noted that this estimate “was based on small numbers and was imprecise.”
While the researchers said their study was “too small” to investigate potential risks for specific defects, they pointed to an apparent increase in the risk for kidney abnormalities. Babies exposed to Zofran were more than six times as likely to be born with renal defects.
Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes
Using a registry of Danish births, researchers from the Statens Serum Institut in Copenhagen investigated whether exposure to ondansetron during pregnancy increased the risk of “adverse fetal outcomes,” including spontaneous abortion, stillbirth, any major birth defect, preterm delivery, low birth weight and small size for gestational age. In all, the study included every registered live-birth or abortion that involved a single fetus in Denmark between January 1, 2004 and March 31, 2011.
After exclusions, this came to 608,385 pregnancies. Only 1,970 of those women were exposed to ondansetron, and the study’s authors concluded by stating that “ondansetron exposure in pregnancy was not associated with a significantly increased risk of major adverse fetal outcomes.”
But perhaps crucially, half of the women studied had first taken ondansetron after 10 weeks of gestation, long after their embryos had developed fully and the risk of developing a birth defect had all but disappeared. This is possibly a flaw that invalidates the study’s findings.
Ondansetron Use in Early Pregnancy & the Risk of Congenital Malformations – A Register Based Nationwide Cohort Study
In reaction to the Statens Serum Institut’s conclusions, a separate group of Danish researchers reviewed the same set of data, but expanded the search, including 903,207 births between 1997 and 2010.
Out of those pregnant women, 1,368 redeemed prescriptions for ondansetron during the first trimester, when the risk of fetal malformation is highest. In line with the hypothesis that ondansetron causes birth defects, 4.7% of the women exposed to the drug gave birth to babies with congenital (“from birth”) malformations, compared to only 3.5% in the unexposed population.
Ultimately, the researchers “found an increase in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription of ondansetron in the first trimester of pregnancy.” Children born to mothers who took ondansetron were 4.8 times more likely to suffer from “Atrioventricular Septal Defects,” a group of conditions in which the heart fails to form properly.
You can find more information on the risks of congenital heart defects here.
Use of Ondansetron During Pregnancy and Congenital Malformations in the Infant
Using data from the Swedish Medical Birth Register, researchers from Stockholm’s National Board of Health & Welfare identified a total of 1,349 infants born to women who had been exposed to ondansetron in early pregnancy between 1998 and 2012.
Compared to women who were never prescribed the drug, women given ondansetron were at an increased risk of delivering babies with “a cardiovascular defect and notably a cardiac septum defect.” Cardiac septum defects, in which the chambers of the heart are never adequately separated from one another, were 1.62 times more likely after exposure to ondansetron.
Fatal Cardiac Arrest in 2 Children: Possible Role of Ondansetron
Earlier this year, two pediatric patients, a 10 year old boy and an 86-day-old infant, presented to an ER in Pennsylvania with symptoms of gastroenteritis. According to the physicians on call, ondansetron is “commonly used [off-label] to treat vomiting” in this condition, which is caused by an inflammation of the intestistines. The physicians administered the drug, and both patients suffered forms of tachycardia which led to ventricular fibrillation and death.
The doctors were so troubled by the deaths that they published an account in the journal Pediatric Emergency Care. Their report concluded by saying that in conjunction with other factors, ondansetron “could result in […] adverse effects, such as arrhythmias.”
Birth Defects Blamed On Unapproved Morning Sickness Treatment
Analyzing a Canadian database of adverse medical events, the Toronto Star found at least 20 pregnant women, prescribed Zofran or generic ondansetron, whose babies suffered from serious birth defects. The complications included “two infant deaths and multiple cases of newborns with heart defects and kidney malformations.”
While these reports are not necessarily proof that ondansetron causes birth defects, prominent Canadian pediatrician Gideon Koren said that the serious side effects are a “signal that should be looked into.”
Notably, Koren was the first to investigate Zofran’s potential risks for developing babies. In 2004, he published a paper that found no evidence of increased dangers caused by ondansetron in pregnant women. But at the time, Koren repeatedly stated that his study’s sample size was so small that it “could rule out only a 5-fold increased risk of major malformations.” If the danger of a congenital defect was “only” 200% or 300% greater, Koren’s study would not have been able to detect it.
By 2013, Koren had reversed his position, writing in the Pediatric Times that “new and troubling evidence suggesting that the drug may be associated with increased risks during pregnancy – both maternal and fetal – has recently become available.”
Plaintiffs in the newly-filed Zofran birth defect lawsuits have noted that all of the studies mentioned above, even those that ultimately found an increased risk of birth defects associated with ondansetron, include “methodological characteristics tending to bias [their] results toward under-reporting the true risk of having child with a birth defect.”
Zofran Birth Defect Lawsuits
In the wake of GlaxoSmithKline’s $3 billion settlement, a wave of new research may be establishing a potentially devastating link between Zofran, birth defects and a wide range of other severe medical conditions. Even more disturbingly, seven lawsuits filed so far in 2015 allege that GSK has been aware of Zofran’s dangers for years, hiding reports of fetal abnormalities and failed animal studies from FDA regulators and physicians alike.
If the allegations in these lawsuits prove true, one might conclude that GlaxoSmithKline may have had blatant disregard for public safety and endangered the lives of perhaps thousands, forcing numerous families to bear extreme emotional and financial burdens. If you belong to one of those families, we urge you to contact an experienced personal injury attorney immediately.
Did you give birth to a child with birth defects after taking Zofran for morning sickness? This is not your fault. GlaxoSmithKline traded your child’s health for record profits. But you can hold them accountable, and secure significant compensation, by filing a personal injury lawsuit.
The attorneys at Monheit Law can help. Call 866-761-1385 today for a free consultation. Speak with an experienced lawyer and get the answers you need, at no charge and no obligation.