When the anti-nausea drug Zofran is used during pregnancy, studies have found a 30% increased risk of birth defects, a doubled risk of “hole in the heart” defects, and even higher rates of cleft lip and cleft palate.
Zofran Lawsuits Centralized in MDL
In October 2015, federal judges centralized Zofran lawsuits into a Multi-District Litigation (MDL No. 2657) in the District of Massachusetts under Judge F. Dennis Saylor. The MDL process has many of the advantages of a class action, like improving efficiency and helping lawyers coordinate discovery, trials, and settlements. As of mid-December 2016, the MDL contained more than 360 Zofran birth defect lawsuits.
What is Zofran?
Zofran (ondansetron) is an anti-nausea drug that is FDA-approved for chemotherapy and surgery patients. Zofran was created by GlaxoSmithKline (GSK) and has been on the market since 1991. It works by blocking serotonin, a natural substance in the body that causes vomiting. Serotonin has many other functions in the human body, especially during pregnancy. It plays a major role during fetal heart and organ development.
Is Zofran Safe During Pregnancy?
Zofran is not approved for pregnant women. Fetal safety data is based on less than 200 births. The FDA classifies Zofran as a “Pregnancy Category B” medication, which means no one knows if it is safe. Pregnant women with questions about Zofran should talk to their doctors. Zofran has also been linked to deadly side effects for pregnant women.
Zofran Birth Defects
- Heart defects
- Heart murmur
- Atrial septal defect
- Ventricular septal defect
- Hole in the heart
- Cleft lip
- Cleft palate
- Musculoskeletal Defects
- Fetal growth restriction (poor growth in the womb)
- Kidney defects
- And more
Drug-Maker Pays $3 Billion After Marketing Zofran to Pregnant Women
In July 2012, the Justice Department announced a $3 billion settlement with GlaxoSmithKline (GSK) for illegal promotion of several prescription medications and other violations of federal law. The settlement resolved allegations that GSK promoted Zofran for “off-label” use in pregnant women with morning sickness. Click here to read more.
Does Zofran Cross the Placenta?
Yes. According to several studies published in the last decade, Zofran passes from mother to fetus through the placenta very rapidly and in “significant amounts.” Furthermore, it remains active in the fetus much longer than in the mother.
Zofran and Birth Defects
Many studies have found no evidence of an increased risk of birth defects from Zofran. For example, in February 2013, a study published in the New England Journal of Medicine looked at data from 900,000 pregnancies between 1997 and 2010 in Denmark and found no association between Zofran and birth defects — but other studies dispute these results.
Study Links Zofran and Birth Defects
Other researchers have looked at the same data from Denmark, but with more pregnancies and over a longer period of time. In August 2013, they published a study (PDF) linking Zofran with a doubled risk of heart defects, leading to a 30% increased risk of birth defects overall. Of the 1,248 women who used Zofran during the first trimester, 4.7% had a baby with a birth defect, compared to 3.5% of women who did not use Zofran. C
Study Finds 20% Increased Risk of Birth Defects
Many other studies have also found higher rates of birth defect among babies exposed to Zofran. In December 2013, Australian researchers found a non-significant 20% increased risk of birth defects associated with Zofran. The study was published by Biomed Reserach International.
Zofran and Heart Defects
In December 2014, Reproductive Toxicology published a study by researchers in Sweden who found that Zofran doubled the risk of septal heart defects (also known as “hole in the heart” defects) and increased the overall risk of heart defects by 62%. The conclusions were based on data from 1,349 infants whose mothers took Zofran in early pregnancy from 1998-2012. Click here to read more
Zofran and Cleft Palate
Zofran was linked to a 2.4-fold increased risk of cleft palate in a study published by Birth Defects Research in 2012. Conclusions were based on data from over 9,000 pregnant women who participated in the National Birth Defects Prevention Study. Cleft palate occurs when the roof of the mouth fails to seal during early fetal development, resulting in a gap on the roof of the mouth that sometimes extends into the throat or nose. It usually requires surgery in the baby’s first 1-2 years of life.
Zofran and Kidney Defects
Australian researchers found a possible sign of kidney defects when Zofran was linked to a 6-fold increased risk of malformations described as “obstructive defects of renal pelvis and ureter.” Obstructive defects often result in hydronephrosis, which can cause kidney failure. However, conclusions were based on a small sample size and were imprecise. Click here to read more.
Hundreds of Birth Defects Reported
Lawyers say GSK knew or should have known about the risk of birth defects from Zofran. For example, a study published in 2004 found case reports linking Zofran and birth defects, but this risk was never investigated by GSK. By mid-2015, the FDA had 475 reports of birth defects since Zofran was approved in 1991. In 2014, an investigation by the Toronto Star found dozens of babies with birth defects who were exposed to Zofran.
Canada Has Stronger Birth Defect Warnings
The label on the anti-nausea drug Zofran carries stronger pregnancy warnings in Canada than in the United States. The Canadian drug-label for Zofran clearly states that “the safety of ondansetron for use in human pregnancy has not been established,” and “the use of ondansetron in pregnancy is not recommended.” These warnings are not on the label in the U.S. Instead, the label states that Zofran should be used during pregnancy “only if clearly needed.”
FDA Warning: Serotonin Syndrome
In March 2013, the FDA identified a potential safety issue linking Zofran with serotonin syndrome, which can be life-threatening for a pregnant woman and her fetus. Symptoms include cognitive and behavioral changes (confusion, agitation), rapid heartbeat, diarrhea, shivering, muscle rigidity, seizures, high fever, and loss of consciousness.
What is Serotonin Syndrome?
Serotonin syndrome usually occurs when patients use two medications that affect the body’s level of serotonin at the same time, causing too much serotonin to be released in the brain. Many pregnant women on Zofran are also treated with antidepressants, which might increase the risk of this side effect.
In December 2012, a recall was issued for 32-mg intravenous (IV) Zofran after a study linked it to heart rhythm disorders. Zofran may prolong the QT interval, which is how long it takes the heart muscles to “re-charge” between beats. This can lead to Torsade de Pointes.
FDA Warning: Irregular Heart Rhythm
The FDA has issued multiple warnings about the risk of severe irregular heart rhythm from Zofran:
- December 4, 2012 — Safety Communication announces that the 32-mg intravenous (IV) dose of Zofran (the highest dose available) will no longer be marketed due to serious cardiac risks.
- September 2011 — Safety Communication informs the public of an ongoing safety review linking Zofran and abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.
Alternatives to Zofran for Morning Sickness
In the last decade, Zofran became a common “off-label” treatment for severe morning sickness. By 2013, Zofran was being used by 1 million pregnant women per year. This was partly because there was no FDA-approved drug for this condition for about 30 years.
That all changed in 2013, when the FDA approved Diclegis, a “Pregnancy Category A” medication that combines pyridoxine and doxylamine (essentially, Vitamin B6 plus an antihistamine). Unlike Zofran, Diclegis is FDA-approved for morning sickness and its safety is well-established.
Interestingly, Diclegis was originally sold in the 1950s under the brand-name Bendectin, but withdrawn in 1983 after women filed lawsuits claiming Benedectin caused birth defects. The drug re-entered the market after dozens of studies involving more than 250,000 pregnancies found no evidence that the drug would harm a developing baby.
Health experts now say Zofran should only be prescribed as a last-resort for pregnant women when other medications have failed. In December 2014, the American Journal of Obstetrics & Gynecology recommended changes in the way morning sickness is treated: “Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.”
Zofran Class Action Lawsuit
Hundreds of Zofran lawsuits have been filed, but not as part of a class action. Instead, they are individual lawsuits that have been centralized in a Multi-District Litigation (MDL) in Massachusetts. Our attorneys are not currently pursuing justice for our clients through a Zofran class action. Instead, we are filing individual Zofran birth defect lawsuits.
July 10, 2015 — The parents of a boy who was born with clubfoot has filed a federal lawsuit (PDF) in New Jersey claiming the anti-nausea drug Zofran is to blame for his severe orthopedic birth defect. Click here to read more.
June 30, 2015 — The mother of a baby who was born with a “hole in the heart” defect has filed a lawsuit (PDF) against GSK accusing the drug-maker of failing to warn about the birth defect risks associated with Zofran. Click here to read more.
June 29, 2015 — A lawsuit (PDF) has been filed by a mom in Alabama who took Zofran during pregnancy and had a baby with life-threatening “hole in the heart” defects that required open heart surgery and a pacemaker. Click here to read more.
June 17, 2015 — A lawsuit (PDF) has been filed by the parents of an infant who died of heart defects after her mother took the anti-nausea drug Zofran during her first trimester of pregnancy. Click here to read more.
June 16, 2015 — GSK has been hit with a lawsuit (PDF) by two women who were prescribed Zofran for the “off-label” treatment of morning sickness and had babies with life-threatening heart defects. Click here to read more.
June 5, 2015 — Seven families have filed lawsuit alleging that Zofran causes birth defects, and now at least four studies have found evidence supporting this link. Click here to read more.
May 27, 2015 — A mom from Arkansas who had a baby with cleft lip after taking Zofran in the first trimester has filed a lawsuit (PDF) against GSK for failing to warn about the risk of birth defects. Click here to read more.
May 22, 2015 — A mom from Oakland, California has filed a lawsuit (PDF) against GSK after she took Zofran during pregnancy and had a baby with an heart rhythm disorder known as supraventricular tachycardia (SVT), which causes rapid breathing, shallow breathing, and shortness of breath. Click here to read more.
April 24, 2015 —GSK has been hit with a federal lawsuit in Massachusetts by a woman who took Zofran and was forced to terminate her pregnancy after her baby developed severe, life-threatening abdominal birth defects. Click here to read more.
April 22, 2015 — A mother from Texarkana, Texas has filed a federal lawsuit alleging that the anti-nausea drug Zofran caused her child to be born with heart defects, brain defects, developmental delays, and other congenital birth defects. Click here to read more.
April 6, 2015 — The family of a boy who was born with severe chromosomal birth defects after his mother used Zofran during pregnancy has filed a lawsuit against GSK in federal court in Alabama. Click here to read more.
April 8, 2015 — The parents of a girl who was born with a cleft lip and cleft palate after being exposed to Zofran in the womb has filed a lawsuit against GSK for failing to warn about the risk. Click here to read more.
March 30, 2015 — A two year-old girl from Minnesota was born with severe heart defects after she was exposed to Zofran during pregnancy. Click here to read more.
February 19, 2015 — A lawsuit has been filed by a woman from Massachusetts who took Zofran during her first trimester of pregnancy and had a baby with three heart defects, facial deformities, webbed toes, and a number of other birth defects. Click here to read more.