Zofran is an anti-nausea medication often prescribed off-label to women during pregnancy. Sadly, studies link birth defects to Zofran and its generic version ondansetron. The drug’s warning label does not list the increased risk of causing birth defects.
Now many women and their families are filing lawsuits against Zofran’s manufacturer GlaxoSmithKline (Glaxo) for falsely marketing the drug without FDA approval. Court documents claim the drug led to serious injuries to new born children that would not have occurred had Glaxo properly warned the public about its dangerous side effects.
Did your child suffer birth injuries after you took Zofran?
You and your family may be entitled to compensation to help pay for medical bills, emotional trauma and birth injuries related to Zofran.
What is Zofran?
Zofran is a prescription drug used to prevent nausea and vomiting in cancer and post-surgery patients. The drug works by blocking one of the body’s natural substances, serotonin, that causes vomiting. There are various methods of delivery of the drug including oral tablets, liquid and intravenous (IV) injection.
The U.S. Food and Drug Administration (FDA) approved the drug in 1991 for the limited used of treating nausea and vomiting after surgery; and nausea and vomiting related to chemotherapy and radiation treatments.
Over the next few years, Zofran became a top selling drug in the United States. In the first nine months of 2006, it recorded $1.3 billion in sales. That same year, the drug’s patent protection expired and the FDA granted approval for a generic version called ondansetron.
Zofran Marketed for Unapproved Use
With a generic version now available to cancer patients, GlaxoSmithKline began exploring alternate markets for Zofran. At the time, morning sickness did not have an approved FDA treatment. The company began marketing its drug to women suffering from morning sickness and the more severe version of morning sickness called hyperemesis gravidarum.
In 2012, GlaxoSmithKline paid a $3 billion settlement to the U.S. Department of Justice to resolve civil allegations that it promoted several drugs for off-label uses, including Zofran for the treatment of morning sickness in pregnant women. The drug maker also pled guilty to federal charges of fraud and illegal promotion of several drugs, including that the company paid kickbacks to health care professionals to promote and prescribe Zofran.
Zofran Pregnancy and Birth Injury Risks
Even though they are not FDA approved to treat morning sickness, Zofran and ondansetron are often still prescribed to women during pregnancy. Recent studies suggest that taking Zofran, especially in the first trimester, increases the risk of birth injuries. Unfortunately, morning sickness is often worse during the first trimester, and women are more likely to be prescribed the drug during this critique time of development.
Zofran studies have found links to the following birth injuries:
- Cleft lip and cleft palate
- Heart defects, such as:
- Atrial Septal Defect (ASD), or a “hole in the heart”
- Ventricular Septal Defect (VSD), also referred to as a “hole the heart”
- Tetralogy of Fallot (TOF), a heart defect which causes oxygen-poor blood to flow out of the heart
- Hypoplastic Left Heart Syndrome (HLHS), where the left side of the heart cannot supply blood to the body properly
- Renal agenesis; one or both kidneys fail to develop
- Other organ malformations
Zofran Medical Studies
Zofran has never been approved to treat morning sickness in pregnant women. In addition, very little is known about the safety of Zofran’s use during pregnancy. What studies have been done suggest that taking Zofran, especially during the first trimester, increases the risk of birth effects.
Various institutions have conducted studies to determine the effects of Zofran use during pregnancy. The most recent study, published in the December 2014 issue of The American Journal of Obstetrics and Gynecology found that taking Zofran, especially during the first trimester, increases the risk of severe birth defects.
A 2013 Danish study reviewed a national registry of 900,000 birth records from 1997 to 2010 and found a 30 percent increased risk of birth defects and a twofold increase in risk of heart defects attributed to the mother taking Zofran.
Other research includes:
- In 2012, the Center for National Birth Defects Research and Prevention found a 2.4-fold increased risk for cleft palate and cleft lip when Zofran was taken during pregnancy.
- In 2012, the FDA issued a safety warning that patients taking Zofran have an increased risk of suffering a potentially fatal arrhythmia Torsade de points. The warning recommended that patients with certain electrolyte abnormalities, caused by severe nausea and vomiting, undergo ECG monitoring while taking Zofran.
- In 2014, the Toronto Star, a Canadian newspaper, conducted a Zofran investigation and reviewed 2012 records from the FDA’s public side-effect report database. Reporters discovered that at least 20 Canadian women treated with Zofran during pregnancy reported newborns with serious birth injuries including heart defects and kidney malformations. Two infant deaths were also reported.
Dr. Gideon Koren, M.D., a professor of pediatrics, pharmacology, pharmacy, medicine and medical genetics at the University of Toronto, wrote the following about Zofran in the Oct. 25, 2013, edition of Pediatrics News:
If you or a loved one is currently taking Zofran, talk to a doctor before discontinuing use. Always discuss the benefits and risks of discontinuing use of any medication with a physician.