Pregnant women who take the anti-nausea drug Zofran for morning sickness may be 30% more likely to have a baby with a birth defect, and twice as likely to have a heart defect or cleft palate, according to recent studies.
UPDATE: With Over 250 Lawsuits Filed, Study Disputes Birth Defect Risk
May 16, 2016 — With over 260 Zofran lawsuits now pending, a new study has found no evidence of an increased risk of birth defects. Click here to read more.
November 4, 2015 — At least 193 Zofran lawsuits have been filed on behalf of babies with birth defects, including dozens filed last week in Alabama and Massachusetts. Click here to read more.
October 14, 2015 — Federal judges have centralized Zofran lawsuits into a Multi-District Litigation (MDL No. 2657) in the District of Massachusetts under Judge F. Dennis Saylor. Click here to read more.
October 1, 2015 — With dozens of Zofran lawsuits filed, federal judges met today to decide whether to centralize the litigation into a Multi-District Litigation (MDL). Click here to read more.
September 18, 2015 — A mom from Mississippi has filed a lawsuit (PDF) claiming her son’s cleft palate was caused by her use of Zofran during pregnancy. Click here to read more.
August 10, 2015 — A lawsuit (PDF) has been filed by the parents of a boy who was born with only one low-functioning kidney after he was exposed to Zofran in the womb. Click here to read more.
July 23, 2015 — The family of a boy who was born with a heart defect known as Tetralogy of Fallot has filed a lawsuit (PDF) claiming Zofran is responsible. Click here to read more.
July 17, 2015 — The FDA has received 475 reports of birth defects and other fetal adverse outcomes linked to Zofran since it was approved in 1991, according to a Freedom of Information Act (FOIA) investigation. Click here to read more.
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.
July 7, 2015 — GSK has asked a panel of federal judges to centralize a dozen lawsuits into one federal court in Pennsylvania. 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 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 16, 2015 — The label on the anti-nausea drug Zofran carries prominent pregnancy warnings in Canada, but not in the United States. 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.
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.
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.
March 23, 2015 — Studies linking Zofran and a potential risk of birth defects has been growing for years, which adds evidence to lawsuits alleging that GSK knew or should have known about the risk. Click here to read more.
March 19, 2015 — FDA warns about heart problems from Zofran, which could be very serious for pregnant with electrolyte imbalances due to severe morning sickness. Click here to read more.
March 18, 2015 — Using Zofran during pregnancy could increase the risk of having a baby with a heart defect by 62% and double the risk of “hole in the heart” defects, according to a study published in Reproductive Toxicology by Swedish researchers. Click here to read more.
March 13, 2015 — A study published in Pediatric Emergency Care reports on two children who died from heart problems after being given ondansetron, the active ingredient in Zofran. Click here to read more.
February 23, 2015 — A woman from Minnsota who had two children with heart defects after taking Zofran has filed a lawsuit (PDF) against GSK. 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.
Investigation Links Zofran and Birth Defects
December 9, 2014 — The Toronto Star reports that birth defects have been linked to Zofran, an anti-vomiting medication that is commonly prescribed to pregnant women. Click here to read more.
Some of the most devastating outcomes included:
- Two fetal deaths
- Fetal growth restriction (IUGR) in six infants, including four babies who weighed as little a 4.5 pounds. This condition involves very poor growth in the womb, in the bottom 10th percentile for gestational age.
- One baby was born with a “musculoskeletal abnormality”
- Multiple reports of heart defects and kidney malformations
- One doctor suspected Zofran was the cause of a baby’s mouth deformity, jaundice, heart murmur, and two heart defects, including atrial septal defect (“hole in the heart”)
What is Zofran?
Zofran (generic: ondansetron) is an anti-nausea drug sold by GlaxoSmithKline (GSK). It was approved by the FDA in 1991 for the prevention of nausea and vomiting in patients recovering from chemotherapy or surgery.
During the first three months of pregnancy, about 70-85% of women suffer from nausea and vomiting during the first trimester. It’s called “morning sickness,” though it can occur at any time of day.
About 1% of women develop extreme morning sickness — hypermesis gravidarum — which poses serious health risks to both mother and fetus. Symptoms include uncontrolled vomiting requiring hospitalization, dehydration, nutritional deficiencies, electrolyte imbalances, acidosis, and loss of more than 5% of pre-pregnancy body weight.
Zofran and Morning Sickness
In the last 30 years, Zofran has gained popularity as an unapproved, “off-label” treatment for extreme morning sickness. Part of the reason was because there was no FDA-approved treatment for morning sickness for over 30 years.
That ended in 2013, when the FDA approved Diclegis, a combination of pyridoxine and doxylamine (Vitamin B6 plus an antihistamine). Diglegis is classified as “Pregnancy Category A.” Its safety is well-established in dozens of studies involving more than 250,000 pregnancies.
Is Zofran Safe to Use During Pregnancy?
Zofran is not FDA-approved for treating morning sickness during pregnancy. There are no well-controlled studies in pregnant women, and its fetal safety data is based on less than 200 births. It is a “Pregnancy Category B” medication, which means animal studies have found no evidence of birth defects, but no one knows if it is safe to use during pregnancy. In addition to birth defects, Zofran is associated with deadly side effects for pregnant women.
Does Zofran Cross the Placenta?
Yes. Several studies published in recent years have found that Zofran rapidly crosses the placenta, passes from mother to fetus in “significant amounts,” and remains active in the fetus much longer than it does in the mother. Click here to read more.
Zofran Pregnancy Risks
Our attorneys are evaluating cases involving:
- Birth defects
- Heart defects
- Heart murmur
- Atrial septal defect
- Ventricular septal defect
- Hole in the heart
- Cleft lip
- Cleft palate
- Fetal growth restriction (poor growth in the womb)
- Musculoskeletal defects
- Kidney defects
- And More
Studies Link Zofran and Birth Defects
In February 2013, the New England Journal of Medicine published a study that found no link between Zofran and birth defects.
Their conclusions were based on data from a registry of pregnancy outcomes in Denmark between 2004 and 2011. It was limited because half of the women started taking Zofran after the 10th week pregnancy, when their baby was no longer at risk of many birth defects, including heart defects and cleft lip.
However, just six months later, another team of researchers led by Dr. Jon A. Andersen looked only at data involving Zofran use in the first trimester. They found that Zofran doubled the risk of heart defects, leading to a 30% increased risk of birth defects overall.
Dr. Andersen’s conclusions were based on more pregnancies (nearly 900,000) and over a longer period of time (1997-2010). Nearly 5% of the 1,248 women who used Zofran during pregnancy had a baby with a birth defect, compared to 3.5% of women who did not. To check for confounding factors, researchers also looked for birth defects associated with the anti-nausea drug metroclopramide, but found no association.
Findings of this study are backed up by one published in Reproductive Toxicology in December 2014, which linked Zofran to a doubled risk of “hole in the heart” defects and a 62% increased risk of heart defects overall.
Another study published in BioMed Research International by Australian researchers linked the use of Zofran in the first three months of pregnancy with a non-significant 20% increased risk of birth defects. A possible increased risk of kidney defects was also observed, although the study was too small to make any conclusions about individual birth defects. Click here to read more.
What is the alternative?
In 2013, the FDA re-approved pyridoxine-doxylamine after data on more than 250,000 births found no evidence of fetal risks. It is now marketed under the brand-name Diclegis. It is a “Pregnancy Category A” medication that is specifically approved for the treatment of nausea and vomiting during pregnancy.
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.”
Type of Zofran Heart Defects
Heart defects linked to Zofran include:
- Atrial septal defect: Hole in the wall between the two upper chambers of the heart.
- Ventricular septal defect: Hole in the wall between the two lower chambers of the heart.
- Heart murmur: Abnormal sound (clicking, whooshing, etc.) heard in the heart using a stethoscope.
Study Links Zofran and 2X Risk of Cleft Palate
In January 2012, Zofran was associated with a 2.4-fold increased risk of cleft palate in a study published in Birth Defects Research. The results of the study were based on data from over 9,000 pregnant women in the National Birth Defects Prevention Study.
What is Cleft Palate?
Cleft palate is a birth defect in which the roof of the baby’s mouth fails to develop. All babies are born with a cleft palate, but tissue normally grows into a “hard palate” and “soft palate” during weeks 6-9 of pregnancy. Click here to learn more.
Babies who are born with cleft palate have an opening in the roof of their mouth, which may connect to the nose, gums, and upper lip. It can interfere with feeding and often requires reconstructive surgery.
What is Cleft Lip?
Cleft lip is a birth defect that occurs between weeks 4-7 of pregnancy, when the tissue of the upper lip does not join together properly. This results in an opening in the upper lip — on one or both sides of the lip, or the middle of the lip. Mild cases involve only tiny notches. Severe cases involve a large opening that goes through the lip to the nose and may connect to a cleft palate. Click here to learn more.
GSK Pays $3 Billion for Illegal Marketing of Zofran, Other Medications
In July 2012, the Justice Department announced that GlaxoSmithKline will pay a $3 billion settlement for many violations, including promoting Zofran for pregnant women with morning sickness and paying kickbacks to doctors who prescribed the drug. Federal law prohibits pharmaceutical companies from marketing drugs “off-label” for uses that are not approved by the FDA.
In March 2013, the FDA warned about a potential risk of serotonin syndrome from Zofran and other drugs in its class.
Zofran works by influencing serotonin levels. The risk of serotonin syndrome could be higher for people who also use SSRI antidepressants, which treat depression by increasing serotonin levels.
Pregnant women who develop serotonin syndrome may develop side effects that could be life-threatening or cause birth defects. These side effects include seizures, high fever, loss of consciousness, muscle rigidity, diarrhea, shivering, confusion, agitation, and rapid heartbeat.
Zofran and Heart Rhythm Problems
September 2011 — The FDA has published a Safety Communication to warn that Zofran may increase the risk of heart rhythm irregularities that could lead to a life-threatening disorder known as Torsade des pointes. During pregnancy, this side effect could be fatal for both mother and child.
December 4, 2012 — The FDA has published a Safety Communication to warn that the 32-mg dose of Zofran will no longer be marketed due to the risk of deadly cardiovascular side effects. Click here to read more.
Following a 2-year investigation, the FDA has issued a recall for 32-mg intravenous (IV) Zofran due to the risk of deadly heart rhythm disorders. The FDA began investigating the problem in 2011 and ordered GlaxoSmithKline to conduct new safety studies. Concerning results of those studies led the FDA to pull the highest dose of Zofran off the market.
Symptoms of An Irregular Heart Rhythm
While most irregular heart rhythms do not present symptoms and can only be detected through a doctor’s exam or an electrocardiogram (ECG, EKG), some warning signs of a possible irregular heart rhythm include:
- Heart palpitations (fluttering heart beat)
- Pounding in your chest
- Shortness of breath
- Chest discomfort
- Weakness or fatigue