Zofran is a prescription medication used to prevent nausea and vomiting in chemotherapy patients or in patients who just had surgery. The anti-nausea medication is often prescribed “off-label” to another group of people who experience nausea and vomiting: pregnant women. Zofran has not been approved to treat morning sickness and has not been proven safe for pregnant women or their developing babies. Nonetheless, more than 110,000 Zofran prescriptions were written each month to pregnant women in 2013, more than double the 50,000 monthly prescriptions written in 2008. Some women who took Zofran during their pregnancy say their children were born with birth defects and studies have been published that link the drug to cleft palate and heart defects. Lawsuits are now being filed nationwide against Zofran’s manufacturer, GlaxoSmithKline.
Zofran Birth Defects Lawsuit
Women who took Zofran for morning sickness during their pregnancy and gave birth to children with birth defects are filing lawsuits against the makers of the drug, GlaxoSmithKline.
If you took Zofran during pregnancy and your child was born with a birth defect, including cleft palate or heart defects, you may be entitled to financial compensation. There may be significant payouts or cash settlements for those affected by the drug.
Zofran was never approved to treat morning sickness and studies have linked the drug to certain birth defects.
Lawyers and attorneys are actively accepting cases nationwide involving Zofran and its potential risks. Hundreds of lawsuits have already been filed against GlaxoSmithKline, accusing the drugmaker of multiple legal claims, including:
- Designing a defective product
- Failing to warn about Zofran’s risks
Zofran lawsuits filed in federal court were consolidated into a multidistrict litigation (MDL) in October 2015. The Judicial Panel on Multidistrict Litigation coordinated the lawsuits in Massachusetts with U.S. District Judge F. Dennis Saylor presiding. There were more than 360 lawsuits pending in the MDL as of April 17, 2017.
MDLs are established when a number of plaintiffs allege similar claims against a corporation. Plaintiffs in Zofran lawsuits all claim to have taken the drug during pregnancy and had babies born with certain birth defects as a result.
Consolidating similar cases allows attorneys and lawyers to pool their resources during the discovery process and save the court system time and money. It can also help encourage settlement negotiations.
MDLs are different from class action lawsuits in that cases are filed individually, not by one plaintiff on behalf of many. Jury awards are also handed down individually should the cases head to trial, and settlements are doled out based on individual injuries, not divided equally among the plaintiffs.
What is Zofran?
Zofran is an anti-nausea medication originally manufactured by British pharmaceutical company GlaxoSmithKline. The drug is now sold by the Swedish company Novartis.
The U.S. Food and Drug Administration first approved Zofran in 1991 to treat nausea in patients undergoing chemotherapy. It was later approved to treat nausea in patients who underwent surgery. Zofran is used to treat adults and children, including infants as young as 1 month.
Zofran has never been approved to treat nausea in pregnant women, yet doctors have often prescribed the drug “off-label” to women experiencing morning sickness. GlaxoSmithKline paid $3 billion to the federal government in 2012 to settle accusations it was promoting Zofran as a treatment for morning sickness and paying doctors kickbacks to prescribe the drug for this use. At the time, it was the largest health care fraud settlement in U.S. history.
Zofran has not been adequately tested to ensure it is safe for mothers and their developing babies. The FDA classified Zofran as a “Pregnancy B” drug, which means animal studies have been conducted and do not show a clear risk to the fetus. However, the drug has not been tested in humans and animal studies have “reported inconsistent findings,” according to the Zofran label.
Many women who took Zofran during pregnancy said their children were born with birth defects, including heart defects and cleft palate. These women are now filing lawsuits against Zofran’s manufacturer, accusing the company of designing a defective product and failing to warn about its risks.
Zofran Side Effects
There is a risk of side effects when taking Zofran for any indication. The side effects are usually mild, but some can be severe or even life-threatening.
The most common side effects of Zofran are:
Other more rare side effects are also possible. These include:
- Chest pain
- Low blood pressure
- Rapid heart rate
- Low potassium
- Movement disorders
- QT prolongation
- Torsades de Pointes
Zofran and Pregnancy
Zofran is sometimes prescribed “off-label” to pregnant women suffering from morning sickness and its more severe form, hyperemesis gravidarum. Hyperemesis gravidarum is a serious condition that can be dangerous to both mother and baby. When a woman develops this condition during pregnancy, the vomiting can be so severe it results in a dangerous loss of fluids, dehydration, electrolyte imbalances and weight loss.
Women and their doctors must weigh the risks and benefits of taking Zofran during pregnancy, since there have been no adequate clinical trials conducted to test its safety in developing fetuses.
This is why it is so important for Zofran’s manufacturers to provide doctors with all of the information about Zofran and its safety and effectiveness. Zofran lawsuits contest, however, that GlaxoSmithKline did not adequately warn about Zofran’s risks, so doctors and women could not make totally informed decisions about the risks and benefits.
There have been a limited number of studies published that show Zofran can increase the risk of birth defects when mothers take it during pregnancy. These studies used data from birth and prescription drug registries and found an increased risk for heart defects and cleft palate.
Two studies published in 2013 and 2014 found the risk for heart defects in newborns increased about two-fold when their mothers took Zofran during pregnancy; and another study published in 2011 found the risk of babies born with cleft palate increased more than two-fold for women taking Zofran during the first trimester.
Possible Zofran Birth Defects
Zofran has been linked to birth defects in babies whose mothers took the drug during pregnancy. These birth defects include heart defects and cleft palate.
Heart defects are a possible risk of Zofran when taken during pregnancy. These heart defects are called cardiac septal defects and include Atrial Septal Defects (ASD) and Ventricular Septal Defects (VSD).
Babies with ASD are born with a hole in the wall separating the top two chambers of the heart. Babies with VSD are born with a hole in the wall separating the two lower chambers of the heart. Both defects can be life-threatening if not treated and they may require surgery.
Atrial Septal Defect
All babies are born with an opening between the upper two chambers of the heart, but the hole usually closes within several weeks or months after the baby is born.
If a baby is born with ASD and the hole does not close, extra blood pumps into the lungs, making the heart and lungs work harder than normal. This additional stress can cause damage over time.
Babies born with ASD may require open-heart surgery to treat the defect.
Ventricular Septal Defect
Babies born with VSD may have difficulty feeding and growing at a normal rate compared to newborns without the defect. Symptoms of VSD usually do not occur until several weeks after birth.
Similar to ASD, VSD allows more blood to flow into the lungs, which can cause permanent damage over time. Open-heart surgery may be necessary to repair VSD.
Cleft palate is a birth defect that causes a split or opening in the roof of the mouth and occurs when the tissues do not join together completely during development.
Cleft palates can cause eating problems, ear infections, hearing loss, speech and dental problems in babies.
Surgery is necessary to repair a cleft palate and is recommended within the first 18 months of a child’s life. In some cases, more surgeries may be necessary as the child gets older.
Surgery can help improve breathing, hearing, speech and language development.
The FDA has issued several warnings about Zofran’s potential to cause serious heart problems in patients. The agency first warned about these risks in a 2011 safety communication. New data from a clinical study showed the 32 mg single dose could affect the electrical activity of the heart and lead to a condition called Torsades de Pointes. This heart condition is characterized by an abnormal heart rhythm and can be fatal in some people.
The agency updated its warning in 2012 and said doctors should not give patients more than 16 mg of Zofran in a single dose. The following December, the 32 mg dose was discontinued.
Studies on Zofran & Birth Defects
Multiple peer-reviewed studies have been published showing an increased risk for certain birth defects when taking Zofran during early pregnancy.
Obstetrics and Gynecology, 2016
A study published in May 2016 in the journal Obstetrics and Gynecology found a small but significant increase in the risk for fetal heart defects when taking Zofran during pregnancy.
The study was a review of 8 previously published studies involving women who took Zofran during the first trimester of pregnancy. Two of the studies found a two-fold increased risk for heart defects in babies born to mothers who took Zofran.
The study author concluded Zofran should only be reserved for those women whose symptoms are not well-controlled under alternative treatment methods.
Reproductive Toxicology, 2015
A study published in the journal Reproductive Toxicology in December 2015 found a significantly increased risk for heart defects in infants whose mothers took Zofran during pregnancy.
The study looked at data from the Swedish birth registry and the Swedish prescription drugs registry and identified more than 1,300 babies whose mothers took Zofran during pregnancy between 1998 to 2012.
The authors found there was a 62% increased risk for fetal heart defects when taking Zofran during pregnancy.
Centers for Disease Control and Prevention Study, 2011
The Centers for Disease Control and Prevention (CDC), along with researchers at Harvard and the Center for Birth Defects Research and Prevention in Boston, published a study in 2011 on Zofran and the risk of cleft palate.
The study, published in Birth Defects Research Part A: Clinical and Molecular Teratology found an increased risk for cleft palate in infants whose mothers took Zofran during pregnancy. Researchers used data from the National Birth Defects Prevention Study and found a two-fold increased risk of cleft palate in babies who were exposed to Zofran in the womb.
Zofran is approved for both adults and children as young as 1 month. Dosing differs for each patient depending on their age, weight and treatment needs.
Tablets – Zofran ODT – Oral Solution
Zofran is also available in tablets, orally disintegrating tablets (Zofran ODT) and an oral solution. Zofran tablets and Zofran ODT are available in 4 mg and 8 mg strengths; the oral solution is available only in a 4 mg dose.
The recommended dose depends on the patient’s age, weight and treatment needs but should not exceed more than 16 mg in a single dose. This is because any dose higher can increase a person’s risk for developing Torsades de Pointes — an abnormal heart rhythm that could be fatal.
Zofran is available as an injection and is administered intravenously (IV) or intramuscularly. The recommended dosage is 0.15 mg per 1 kg of body weight per dose. Typically, 3 doses are administered over 15 minutes.
The Zofran label warns that no more than 16 mg should be given at one time because of the increased risk of heart rhythm problems.
Zofran is available as a generic and is sold under its chemical name ondansetron. Generic drugs are as effective as their brand-name counterparts but typically cost much less. The price of generic Zofran is about $13 for 30 tablets (4 mg), compared to $200 for the same amount of brand-name Zofran.
Most insurances do not cover Zofran or its generic, but manufacturer coupons and discount programs are available to help with prescription costs.
Zofran lawsuits do not involve the generic form of Zofran.
American Journal of Obstetrics and Gynecology. “Treating morning sickness in the United States–changes in prescribing are needed.” Koren G. (December 2014). Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25151184
Judicial Panel on Multidistrict Litigation. “MDL Statistics Report – Distribution of Pending MDL Dockets by District.” (April 17, 2017). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-April-17-2017.pdf
U.S. Department of Justice. Press Release. “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data.” (July 2, 2012). Retrieved from https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report.
FDA. Zofran Label – Injection. (February 2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020007s047lbl.pdf
FDA. Zofran Label – Tablets (2016). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf
FDA. Safety Communication. “FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran).” (June 2012). Retrieved from https://www.fda.gov/drugs/drugsafety/ucm310190.htm
FDA. Safety Communication. “FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron).” (September 2011). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm271913.htm
FDA. Safety Communication. “FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products.” (December 2012). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm330049.htm
Centers for Disease Control and Prevention. “Facts about Cleft Lip and Cleft Palate.” (November 2015). Retrieved from https://www.cdc.gov/ncbddd/birthdefects/cleftlip.html
American Heart Association. “Ventricular Septal Defect (VSD).” (October 2016). Retrieved from http://www.heart.org/HEARTORG/Conditions/CongenitalHeartDefects/AboutCongenitalHeartDefects/Ventricular-Septal-Defect-VSD_UCM_307041_Article.jsp#.WPm8wVMrJD1
American Heart Association. “Atrial Septal Defect (ASD).” (March 2016). Retrieved from http://www.heart.org/HEARTORG/Conditions/CongenitalHeartDefects/AboutCongenitalHeartDefects/Atrial-Septal-Defect-ASD_UCM_307021_Article.jsp#.WPm8wlMrJD1
Obstetrics and Gynecology. “Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review.” Carstairs SD. (May 2016.) Retrieved from Carstairs SD1.https://www.ncbi.nlm.nih.gov/pubmed/27054939
Reproductive Toxicology. “Use of ondansetron during pregnancy and congenital malformations in the infant.” Danielsson B. et al. (December 2014). Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25450422
Birth Defects Research Part A: Clinical and Molecular Teratology. “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects.” Marlene Anderka (November 2011). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/