Zofran lawsuit attorneys are investigating product liability claims on behalf of patients across the country who believe they have suffered birth defect injuries from Zofran, an anti-nausea medication sometimes prescribed off-label to pregnant women struggling with severe morning sickness. These complaints allege that Zofran, which has never been approved by the U.S. Food and Drug Administration (FDA) as a safe and effective treatment for morning sickness in pregnant women, caused their children to experience major congenital malformations due to the medication’s ability to pass through the human placenta and interfere with the development of unborn babies. If you took Zofran while pregnant, and your child was born with a cleft lip, heart malformation, club foot, or another serious birth defect, contact an experienced Zofran birth defect lawyer today for legal help.
Zofran (ondansetron) is a 5-HT3 receptor antagonist drug commonly used alone or with other medications to reduce symptoms of nausea and vomiting caused by chemotherapy or radiation therapy in cancer patients, or in patients undergoing surgery. In some cases, Zofran is prescribed off-label to pregnant women struggling with a form of morning sickness called hyperemesis gravidarum. Zofran works by blocking the actions of chemicals in the body (5-HT3 receptors) that can trigger nausea and vomiting, preventing nausea messages from being sent from the affected areas of the brain and gut to the vomiting center of the brain.
The problem with Zofran, which first became available for consumer use in 1991, is that the morning sickness drug has been linked to an alleged increased risk of birth defects in babies exposed to the medication in utero. This means that babies whose mothers take Zofran while pregnant may be at risk for congenital malformations like cleft lip and cleft palate, heart defects, lung defects, kidney malformations and skull deformities, among other abnormalities. While some of these birth defects may be treatable or reversible, others can result in long-term difficulties and possibly even death.
For pregnant women facing hyperemesis gravidarum, a severe form of morning sickness characterized by unrelenting, debilitating, pregnancy-related nausea and/or vomiting resulting in complications like dehydration and weight loss, Zofran may seem like a miracle drug, relieving the symptoms of nausea and vomiting, and restoring their ability to perform everyday activities. In reality, Zofran is far from a miracle drug, and it’s important that pregnant women struggling with severe nausea and vomiting during pregnancy are aware of the potential for Zofran to cause birth defects in babies.
Mounting research published in recent years has examined the possible connection between Zofran use in pregnancy and serious birth defects in babies, and in one Zofran birth defect study published in 2012, researchers found that women prescribed Zofran or its generic equivalent during the first trimester of pregnancy were 2.37 times more likely to give birth to a baby with a cleft palate birth defect. That same year, a team of Danish researchers studied the potential adverse effects of Zofran use in pregnancy, and found that babies exposed to ondansetron in utero were 4.8 times more likely to suffer from “atrioventricular septal defects,” a congenital malformation in which the heart fails to form properly during fetal development.
Several newer studies have resulted in similar findings, including one report published in the medical journal Reproductive Toxicology in December 2014, in which researchers found that Zofran use during the first trimester of pregnancy was associated with a 62% increased risk of heart birth defects. That same month, an investigation by the Toronto Star highlighted several cases of alleged Zofran birth defects, including musculoskeletal deformities, multiple reports of kidney defects, six cases of intrauterine growth restriction, two reports of fetal deaths, and one baby’s heart murmur, heart defect, mouth deformity and jaundice.
These revealing studies, along with the lack of initial research done by GSK prior to marketing Zofran as a morning sickness treatment, have raised many concerns about the safety of Zofran use in pregnancy, and have opened the door for affected victims to file Zofran lawsuits against the manufacturer or those who prescribed the medication.
Families across the United States are pursuing legal claims against Zofran maker GlaxoSmithKline, alleging that the drug manufacturing company knew or should have known about the potential for Zofran to cause birth defects in babies. According to allegations raised in these complaints:
If you took Zofran while pregnant, and your baby was born with a congenital malformation like cleft lip or cleft palate, club foot, or a congenital heart defect such as an atrial septal defect or ventricular septal defect, contact a knowledgeable Zofran lawyer today to discuss the possibility of filing a Zofran birth defect lawsuit against GlaxoSmithKline, or to become part of a Zofran mass tort lawsuit.
Zofran has been on the market in the United States for more than 20 years, and statistics show that approximately one million pregnant women in the United States take Zofran or its generic equivalent every year, to treat nausea and vomiting associated with morning sickness. It only recently came to light though, that babies exposed to Zofran in utero may have an increased risk of developing severe birth defects, including the following:
If you took Zofran while pregnant, and your child has suffered from one or more of these malformations, you may be eligible for compensation, which you can pursue by filing a Zofran birth defect claim against GlaxoSmithKline.
One of the first Zofran lawsuits was filed against GSK by the Justice Department in August 2012, accusing the drug maker of illegally marketing Zofran off-label as a treatment for morning sickness in pregnant women, which is a violation of federal law, and GlaxoSmithKline was ordered to pay $3 billion to resolve these criminal charges. In the years since, families across the United States have pursued legal action against GlaxoSmithKline for heart defects, developmental delays, abdominal deformities, facial defects and other congenital malformations affecting babies and young children exposed to Zofran in pregnancy. We are currently investigating a number of Zofran birth defect lawsuits.
A number of complaints have already been brought against GlaxoSmithKline, for birth defects allegedly associated with Zofran use during pregnancy, and more claims are expected to be filed in the future, as families across the country become aware of the alleged link between birth defects and Zofran use by expectant mothers. According to one Zofran birth defect complaint, filed on behalf of a Massachusetts woman in February 2015, use of the anti-nausea drug during pregnancy caused her baby to be born with numerous birth defects, including webbed toes, three different heart malformations and facial deformities. Another lawsuit filed in April 2015 alleged that the mother’s use of Zofran while pregnant caused her baby to suffer from birth defects like heart malformations, brain abnormalities and developmental delays.
The FDA has classified Zofran as a “Category B” pregnancy medication, which means studies in animals have revealed no evidence of impaired fertility or harm to the developing fetus. However, a pregnancy Category B classification also means that there are no adequate or well-controlled Zofran studies involving pregnant women, which doesn’t mean there are no pregnancy risks associated with Zofran. In fact, Zofran has never been approved by the FDA for use in pregnancy, only as a treatment for nausea and vomiting among patients undergoing surgery or chemotherapy treatment.
Despite the alleged risk of birth defects from Zofran use in pregnancy, the FDA has yet to issue an official warning about this risk, and pregnant women across the country continue to use Zofran in early pregnancy, to combat nausea and vomiting associated with morning sickness. The FDA did, however, issue a warning in September 2011, regarding the potential for Zofran treatment to interrupt the electrical activity of the heart in users, which could put patients at risk for an abnormal and potentially deadly heart rhythm problem known as Torsades de Pointes.
In order to provide consumers with accurate information about the potential pregnancy risks associated with Zofran, the FDA is continuing to evaluate this issue to determine the need for any regulatory action. Should the FDA determine that Zofran use in pregnancy exposes unborn babies to severe malformations, the agency may choose to change the pregnancy category of Zofran from Category B to Category C, D, or even X, which means there is positive evidence of human fetal risk based on clinical trials and post-marketing research.
Researchers from all over the world have examined the alleged link between Zofran use by expectant mothers and an increased risk of congenital malformations, and it seems evident that GlaxoSmithKline knew or should have known about the potential for Zofran to interfere with fetal development, even as the drug maker marketed its anti-nausea medication as a morning sickness treatment for pregnant women. At the very least, GlaxoSmithKline should have garnered FDA approval for Zofran use during pregnancy before promoting the drug off-label, in order to ensure the safety and effectiveness of that particular treatment. If you or a loved one took Zofran during pregnancy and gave birth to a baby with a serious birth defect, you may be entitled to financial compensation for your child’s injuries and medical expenses by filing a Zofran lawsuit. Contact us today for a free, no obligation case review.