For years, physicians have been prescribing Zofran to alleviate the symptoms of nausea and vomiting in pregnancy, a condition commonly referred to as “morning sickness” that most pregnant women experience beginning in the first trimester. But Zofran isn’t approved by the FDA for use during pregnancy, and its manufacturer has never studied the drug’s effects on unborn babies.
Four recent epidemiological studies have revealed an association between Zofran’s powerful active ingredient ondansetron and increased risks of major birth defects. Researchers have linked the drug to significantly increased rates of cleft palate, congenital heart defects and kidney malformations.
These results have some experts saying that Zofran and pregnancy are a potentially dangerous combination.
Zofran And Pregnancy: Multiple Lawsuits Claim That Anti-Nausea Drug Causes Birth Defects
Zofranlegal.com is sponsored by Monheit Law, a personal injury firm dedicated to protecting the rights of individuals harmed by dangerous drugs and defective medical devices.
We’ve joined together with a number of attorneys across the country to investigate claims against Zofran’s manufacturer, GlaxoSmithKline (GSK). In this article, we’ll address pressing questions that parents have asked our attorneys about Zofran and pregnancy.
Are Families Filing Lawsuits Against Zofran’s Manufacturer?
At least seven US families have now filed lawsuits against GSK, claiming that prenatal exposure to the company’s anti-nausea drug Zofran caused major child birth defects.
These parents say that GSK unlawfully marketed Zofran to doctors as a safe medication for pregnant women to take, without ever studying the drug’s effects during pregnancy. In fact, they allege that GSK has received substantial evidence to the contrary.
Citing more than 200 reports of birth defects with suspected links to Zofran, and four major epidemiological studies that have found an increased risk of birth defects after exposure to Zofran, plaintiffs claim that GlaxoSmithKline has been aware that Zofran presents an “unreasonable risk of harm” to fetal development since the late 1980s.
According to their allegations, GSK failed to disclose this information to the FDA or public, and continued to promote the drug as a morning sickness treatment in violation of federal law.
What Is Zofran Approved To Treat?
Zofran was approved by the FDA in 1991 to treat severe nausea and vomiting in cancer patients undergoing highly-emetogenic (or “nausea-causing”) treatments like chemotherapy. Several years later, Zofran’s indication was officially extended to include patients who suffer from post-operative nausea and vomiting after receiving surgical anesthesia.
But Zofran and pregnancy? The FDA has never approved Zofran for use in pregnant women. Nor has its manufacturer ever sought approval for that use, or conducted the clinical trials that would be necessary for such an approval.
In fact, upon its initial approval, Zofran had only been tested in pregnant animals. Those studies revealed that Zofran can easily pass through the placental barrier in mammals, entering fetal tissue by way of maternal blood.
Between 1983 and 2013, there was no FDA-approved drug for the treatment of nausea and vomiting during pregnancy. And despite having no evidence of Zofran’s safety in pregnant women, doctors around the world began prescribing it as a morning sickness treatment.
Did GlaxoSmithKline Promote Zofran As An Off Label Morning Sickness Treatment?
This is the claim that multiple families have made in recent Zofran birth defect lawsuits. According to the plaintiff in case 5:15-34, which was filed in the United States District Court for the Eastern District of Texas, Texarkana Division:
“After the FDA approved Zofran […], and despite available evidence showing that Zofran presented an unreasonable risk of harm to prenatal infants exposed to Zofran, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology […] healthcare practitioners, among others, as a safe treatment alternative for Morning Sickness in pregnant women.”
Similar allegations brought by the US Department of Justice in 2012 charged GlaxoSmithKline with promoting Zofran as a treatment for morning sickness at least as early as 2002. Federal prosecutors claimed that GSK had made false or unsubstantiated claims about Zofran and pregnancy, and even paid “illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”
When doctors prescribe medications for unapproved uses, the practice is called “off label” prescription. And while physicians are permitted to prescribe drugs off label, manufacturers are prohibited by federal law from promoting their drugs for unapproved purposes.
Ultimately, the company settled the government’s case for a total of $3 billion, but GlaxoSmithKline has always denied wrongdoing in connection with Zofran’s promotion.
What Is The Link Between Zofran During Pregnancy & Birth Defects?
Multiple independent teams of researchers from across the world have investigated Zofran’s possible effects on developing babies, and now four have returned after finding increased risks of major birth defects.
- In the US, researchers at Harvard and Boston Universities found a 2.37 times increase in the risk of a baby developing cleft palate after being exposed to Zofran during the first trimester.
- In Denmark, scientists reviewed more than 600,000 Danish birth records, and found children born to women who had taken Zofran or a generic equivalent in early pregnancy were between 2 and 4.8 times more likely to be born with congenital heart defects.
- Swedish researchers also reviewed national birth records, spanning the period from 1998 to 2012. They concluded that exposure to ondansetron was linked with a 62% increase in the rate of cardiac septal defects.
- Zofran and pregnancy was also studied by a team from the University of Western Australia. Researchers found that babies exposed to Zofran’s active ingredient were more than six times as likely to be born with rare kidney defects.
You can find more information on birth defects that have been associated with Zofran here.
In addition, plaintiffs have claimed that GSK has received more than 200 reports of birth defects with suspected ties to Zofran. In their complaints, parents say that the company failed to report many of these birth defect records to the FDA.
Can Other Families File Zofran Birth Defect Lawsuits?
If you were prescribed Zofran during the first trimester and gave birth to a child with congenital abnormalities, you may be eligible to bring a claim against GlaxoSmithKline.
Monheit Law is leading a multi-state alliance of attorneys to investigate potential Zofran lawsuits. Our attorneys are available 24 / 7 to answer your questions in a free consultation. Call 1-877-620-8411 or fill out our contact form for more information.