The Food and Drug Administration (FDA) approved Zofran (ondansetron) in 1991 for the treatment of nausea and vomiting in cancer patients going through chemotherapy. The administration never approved the drug for use in pregnant women, but manufacturer GlaxoSmithKline (GSK) promoted it to doctors as an “off-label” treatment for morning sickness.
By the year 2000, GSK had received at least 32 reports of birth defects linked with the use of Zofran during pregnancy. They have since received a total of over 200, but these reports were not disclosed to women or their physicians. As a result, many women who took Zofran and then delivered babies with birth defects have filed Zofran lawsuits in an attempt to recover damages.
GSK Fails to Study Zofran in Pregnant Women
Zofran is part of a class of drugs known as “5-HT3 receptor antagonists.” These types of drugs work by interrupting the message that the brain sends the body telling it to feel nauseated.
Though GSK told doctors that Zofran was a good treatment for expectant mothers suffering from morning sickness, they did so without the support of any clinical trials. The company never conducted any studies of the drug in pregnant women and did not seek FDA approval for use of the drug during pregnancy.
They did, however, conduct animal studies that raised concerns. Back in the 1980s, for example, such studies showed that Zofran was linked with an increased risk of intrauterine deaths and malformations in offspring. The company never warned anyone about the potential risk.
In a 2006 human study, researchers also found that Zofran was able to cross the placental barrier. They tested the drug in 41 patients who requested surgical termination of the pregnancy at the first trimester. Each participant received three doses of the drug at 8 mg each before the surgery. Scientists then collected blood, coelomic fluid, amniotic fluid, and fetal tissue for analysis.
Zofran was found in all samples. In fact, the drug concentration in the fetal tissue was significantly higher than it was in the amniotic fluid or coelomic fluid. “A significant amount of ondansetron was present in all embryonic compartments,” the researchers wrote. They recommended further investigation.
GSK Pays Record-Breaking Fine
Despite these concerning study results, GSK continued to market Zofran as a safe and effective solution for morning sickness. In 2004, the U.S. Department of Justice (DOJ) began investigating the company over concerns they were illegally promoting drugs like Zofran. The department also looked into the company’s marketing practices and sales arrangements.
The investigation was sparked by four former employees of GSK who came forward and revealed what was happening behind closed doors. According to the New York Times, the company eventually settled with the DOJ, pleading guilty to criminal charges and paying $3 billion in fines. This was the largest settlement in history involving a pharmaceutical company.
The DOJ fined GSK for promoting its drugs (including Zofran) for unapproved uses, failing to report safety data involving some of its drugs, improper marketing (bribing doctors with exotic trips and hunting excursions), and overcharging the government for drugs.
GSK’s agreement with the government noted that they “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea).” It also states that they made “false representations about the safety and efficacy of Zofran,” and that they “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”
Other Studies Link GSK with Increased Risk of Birth Defects
After the 2006 study showed that GSK could cross the placental barrier, scientists began looking more closely at the drug. While GSK continued to receive reports of babies born with heart, kidney, and musculoskeletal defects, scientists looked into the potential association.
In 2012, they analyzed data from the National Birth Defects Prevention Study on about 4,500 women who suffered from morning sickness during pregnancy and about 5,800 who didn’t. They found that treatments with drugs like Zofran, particularly in the first trimester, were associated with a potential increased risk of cleft lip and palate and other neural tube birth defects.
A 2012 doctor’s comment in the Canadian Family Physician also questions the drug’s effectiveness in pregnant women, stating that based on the available evidence, it would not be assumed to be safe during pregnancy.
In 2013, Australian researchers evaluated Zofran in women who used it between 2002 and 2005. They found a small increased risk of a major birth defect with first-trimester exposure. The researchers wrote that they “could not conclude that ondansetron is safe to use in pregnancy.”
In 2014, researchers looked at data from the Swedish Medical Birth Register and the Swedish Register of Prescribed Drugs and identified 1,349 infants born to women who had taken Zofran in early pregnancy between 1998 and 2012. They then looked for occurrences of congenital malformations in the babies. They found a significantly increased risk for cardiovascular defects, and notably a cardiac septum—“hole in the heart”—defect.
Types of Birth Defects Associated with GSK
Women who took Zofran in the first trimester of pregnancy may have an increased risk of giving birth to a baby with the following defects:
- Musculoskeletal anomalies
- Mouth deformities
- Cleft lip and palate
- Heart defects, including heart murmurs, atrial septal defect, and ventricular septal defect
In 2012, the FDA also warned that Zofran could increase the risk of heart rhythm problems and serotonin syndrome, which could be harmful to both the mother and the fetus. The Product Monograph for Zofran in the Canadian market warns women and physicians that the safety of Zofran has not been established and that it’s use during pregnancy is not recommended.
In the U.S., Zofran remains a “Category B” drug, which means that no human studies have determined its safety in pregnant women.
Women who took Zofran during early pregnancy and then went on to give birth to a baby with birth defects may be eligible to file a Zofran lawsuit. GSK already faces many of these lawsuits in various courts around the nation.
Plaintiffs claim the company purposely concealed the potential risks associated with the drug, while zealously promoting it for “off-label,” unapproved uses. They also note that GSK did not provide adequate warnings about birth defects on the label, did not perform sufficient safety studies on the drug, and fraudulently claimed Zofran was safe for pregnant women.
A Zofran Lawyer Can Help
If you or a loved one has a child suffering from birth defects caused by Zofran, the attorneys at Chaffin Luhana LLP may be able to help. We understand that manufacturers like GSK are responsible for making sure their products are safe before releasing them on the market. To promote a drug for an unapproved use without making sure it’s safe for that use is irresponsible.
Mothers who took Zofran and then had babies with birth defects often say that they never would have taken the drug had they been aware of the risks. If you’re one of these mothers (or a concerned father), please call today for a free and confidential case evaluation at 1-888-316-2311.