Zofran (ondansetron), an anti-nausea medication made by GlaxoSmithKline (GSK), may increase the risk of heart defects in babies born to mothers who use the drug during pregnancy.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a heart defect after the mother took Zofran while pregnant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: New Jersey Woman Alleges Daughter’s Heart Defects from Zofran
August 3, 2016 – A woman from Hainesport, New Jersey, has filed a lawsuit alleging that Zofran caused her daughter to be born with numerous severe congenital abnormalities, including an atrial septal defect and ventricular septal defect. According to the suit, Plaintiff suffered from morning sickness and migraine headaches during her first trimester of her pregnancy, and was prescribed Zofran to treat these symptoms. Her daughter, “B.B.”, was born on May 13, 2007, and subsequently diagnosed with numerous congenital abnormalities including the heart defects and dysmorphic facial features.
What is Zofran?
The U.S. Food & Drug Administration (FDA) has approved Zofran to treat nausea and vomiting caused by cancer treatment (chemotherapy / radiation therapy) and certain types of surgery. Zofran blocks serotonin – a neurotransmitter in the body that is associated with upset stomach and vomiting – at a specific type of receptor called the 5-HT3 receptor.
Zofran Heart Defects
Zofran is commonly prescribed “off-label” to pregnant women with severe morning sickness. Although the FDA has not approved Zofran for this purpose, it is legal and done at the doctor’s discretion. Unfortunately, when taken during pregnancy, Zofran has been linked to serious birth defects.
In Canada, at least 20 pregnant women who took Zofran for vomiting and nausea had children with severe congenital abnormalities, according to the Toronto Star. Defects associated with Zofran use during pregnancy included:
- Low birth weight
- Intrauterine growth restriction (IUGR)
- Heart defects
- Atrial septal defect (“hole in the heart”)
- Heart murmur
- Musculoskeletal anomaly
- Cleft palate
Danish Researchers Find Risk Of Major Heart Defects with Zofran
In August 2013, Danish researchers presented a study titled “Ondansetron use in early pregnancy and the risk of congenital malformations” at the International Conference on Pharmacoepidemiology in Montreal. The research was prepared in response to an earlier Danish study that found no increased risk of birth defects in babies exposed to Zofran during the first trimester of pregnancy.
The first study looked at Danish birth records from 2004 and 2011; however, as noted by pediatrician Gideon Koren, half of the women reviewed had taken Zofran after they were 10 weeks pregnant. According to Koren, “malformations [can] not be produced” beyond this point.
By widening the cohort to include all Danish births between 1997 and 2010, and including only women who took the drug during the first trimester, the second team of researchers hoped to provide more accurate results than the first.
Of 903,207 live births, 1,368 mothers had filled at least one prescription for Zofran during their first trimester. Among the control group — 901,839 women who did not take Zofran — 3.5% had a baby with a major birth defect. Conversely, 4.7% of the women who used the drug in the first trimester gave birth to children with major congenital malformations.
This disparity was calculated as a 20% increase in the risk for major birth defects, but noted significantly increased risks in regards to congenital heart defects. After being exposed to Zofran in the first trimester, babies were:
- 2.1 times more likely to have atrial septal defects
- 2.3 times more likely to have ventricular septal defects
- 4.8 times more likely to have atrioventricular septal defects
These malformations, referred to as “hole in the heart” defects, involve cardiac tissues that fail to develop properly in the womb.
Swedish Study Finds Increase In Congenital Heart Defects
In Dec. 2014, a group of Swedish researchers investigated Zofran’s effects on fetal development. Their study, published in the journal Reproductive Toxicology, looked at records from Sweden’s Medical Birth Register from 1998 to 2012.
The team found a total of 1,349 babies born to mothers who had been prescribed Zofran during early pregnancy. They then compared the number of congenital defects in that group to defects found among all births that occurred during the 15 year period. They concluded that Zofran use in pregnancy correlated with a “increased and statistically significant” increased risk of cardiovascular defects.
Babies exposed to Zofran in the 1st trimester were 1.62 times more likely to be born with congenital heart defects. The study’s authors noted this risk specifically involved “cardiac septum defects,” a category that includes atrial septal defects, ventricular septal defects and atrioventricular septal defects.
Zofran User Gives Birth to Child With Septal Heart Defects: KVLY News Video
Heart Defect Symptoms
- Difficult or rapid breathing
- Poor weight gain
- Excessive sweating
- Fatigue / fussiness
Treatment and Care
Not all babies born with heart defects require medical intervention. Some may only need to be observed and visit their cardiologist. In other cases, surgery or a cardiac catheterization may be required to repair the defect. Unfortunately, even when a defect is treated during childhood, additional conditions may develop that require further medical treatment.
Babies born with heart defects may be at risk of developing additional problems in the future. These children typically experience delays with physical coordination (i.e. walking and talking), and may have learning difficulties caused by a poor oxygen supply during early life, which affects development of the brain. Natural intelligence is usually unaffected, but some children with congenital heart defects perform well below standard academic levels.
Animal Studies Pivotal in Zofran Heart Defect Lawsuits
Plaintiffs is the Zofran multidistrict litigation (MDL) have called attention to several ‘animal teratogenicity studies’ GSK allegedly performed in Japan after the drug was approved in the U.S. which found a link between Zofran and congenital heart defects. In one of these studies, plaintiffs claim pregnant animals gave birth to offspring with ventricular septal defects (VSD), a congenital heart malformation that has been associated with Zofran use during pregnancy.
“Plaintiffs do not know whether GSK ever provided the FDA this or any other evidence of severe heart defects,” said a letter by the plaintiffs in response to a motion to dismiss the cases by GSK. “What Plaintiffs do know, however, is that the Zofran warning labels and available marketing materials were silent as to such evidence.”
Zofran Heart Defects Lawsuits
Case #CGC-15-544524 – Lawsuit filed March 5 in superior court in San Francisco on behalf of a couple who allege their child was born with bicuspid aortic stenosis, a severe congenital heart defect, after the mother took Zofran for morning sickness during her first trimester of pregnancy. The complaint is the nation’s 4th lawsuit to allege that Zofran caused birth defects.
Case #2:15-cv-00709-PD– A Minnesota woman who took Zofran during pregnancy has filed a lawsuit alleging the drug caused her 2 children to be born with atrial septal defects. The woman claims she was never warned that Zofran is not approved to treat morning sickness, and that GSK should be held liable for her children’s injuries.
Case #RG15761042 – Lawsuit filed in Alameda Superior Court on behalf of a woman who allegedly gave birth to a baby with supraventricular tachycardia after taking Zofran during pregnancy. The defect, which occurs when the heart beats rapidly due to a problem with the organ’s electrical system, causes symptoms including light-headedness, fainting, chest pain, shortness of breath and fatigue.
Case #15-1815 – Two Louisiana mothers filed a joint lawsuit against GSK alleging that their use of Zofran during pregnancy caused their daughters to be born with severe congenital heart defects. The women allege the company illegally marketed Zofran directly to obstetricians and gynecologists as safe and effective for use during pregnancy, despite the drug never being tested in this capacity or receiving approval from the FDA for this purpose.
Case #3:15-cv-1166 – A lawsuit filed by an Ohio woman alleges that she was prescribed Zofran for morning sickness during her 1st trimester of pregnancy, and that her child’s heart rate began to slow a few days before being born. Immediately after delivery, on Mar. 17, 2006, the baby was diagnosed with a right ventricular heart defect, placed in an ICU and died 3 days later.
Case #1:15-cv-00320 – Two lawsuits filed in Alabama federal courts on behalf of women who allegedly gave birth to children with heart defects after taking Zofran for morning sickness in pregnancy. Both women claim they were unaware of the risks associated with Zofran when it was prescribed to them, and that GSK should be liable for their children’s past and future medical expenses.
Case #6:15-cv-01815-RFD-PJHm – Filed June 8 in the Western District of Louisiana by a woman who claims Zofran exposure caused her daughter to be born with the following heart defects: perimembranous ventricular septal defect, atrial septal defect and intermittent tachypnea. The complaint has been transferred to the Zofran multidistrict litigation (MDL) in Boston and assigned to Schedule A.
June 26, 2015 – A Louisiana mother filed a lawsuit today alleging that her son was born with severe heart defects after she took Zofran while pregnant. According to the complaint, the woman used Zofran to symptoms of her morning sickness from early in her 1st thru the 3rd trimester, and gave birth to a boy with heart defects that required 2 corrective surgeries. Plaintiff claims she has no family of heart defects, and blames her use of Zofran for her son’s problems. She seeks general and compensatory damages against GSK.
Case #3:15-cv-00769 – Complaint filed by a single mother from Illinois who claims her son was born with hypoplastic right heart syndrome, or HRHS, after being exposed to Zofran in the womb. As a result of his condition, the boy was forced to undergo a pediatric heart transplant shortly after being born.
Case #1:15-cv-12973 – Filed July 17 in U.S. District Court of the District of Massachusetts by a Winthrop couple who allege their son was born with a ventricular septal defect and heart murmur after the mother took Zofran during pregnancy. The boy, who is now 8-years-old, continues to suffer from the defects and is at risk of developing an infection that could require open heart surgery, according to the complaint.
Case #1:15-cv-01435, 1:15-cv-01436 – Two consecutive lawsuits filed July 20 in U.S. District Court for the Northern District of Ohio, Eastern Division, by mothers accusing GSK of marketing a dangerous drug to pregnant women. Plaintiffs claim their unborn children were exposed to Zofran side effects in 1994 and 1998, at a time when GSK was hiding reports linking birth defects to Zofran, according to the complaints.
Case #3:15-cv-00787 – Lawsuit filed July 21 in U.S. District Court for the Southern District of Illinois on behalf of an Illinois couple who allege their son was born with a severe congenital heart defect called tetralogy of fallot (TOF) after the mother took Zofran during pregnancy. According to the complaint, the child has already undergone open heart surgery and will require additional medical procedures in the future to avoid additional injury.
Case #3:15-cv-00902 – Complaint filed on behalf of a woman whose son was born with a ventricular septal defect after she took Zofran for morning sickness during her first and second trimesters of pregnancy. As a result, the child “experienced severe development delay, cannot run or play hard with other children, and has exhibited emotional challenges due to his injury that was caused by his mother’s ingestion of Zofran.”
Case #2:15-cv-01233-JEO – Lawsuit filed July 24 by an Alabama mother whose son was allegedly born in 2014 with hypoplastic left heart syndrome (HLHS) and unspecified kidney defects after she took Zofran during her first trimester. As a result, the boy has already had to undergo multiple invasive procedures, including a heart transplant.
Case #15-CI-784 – Filed August 5 in the Pike County Circuit Court for the Commonwealth of Kentucky, plaintiffs allege Zofran exposure caused their daughter’s death from heart and kidney defects at the age of 3 months. Complaint is unique in that it is the first to allege post-birth exposure to Zofran, since the family’s pediatrician allegedly prescribed the baby the drug the day before she died.
Case #3:15-cv-00958 – Filed September 4 by a Tennessee mother whose daughter allegedly died from catastrophic heart defects after being exposed to Zofran in the womb.
Case #2:15-cv-01552-TMP – Also filed in Tennessee, this lawsuit was entered on behalf of family whose daughter was born with “multiple congenital anomalies,” including an unspecified heart defect. This complaint is unique in that it names both GSK and a generic ondansetron manufacturer as defendants.
Case #2:15-cv-01638-RDP – Filed September 8 in the Northern District of Alabama, Southern Division, on behalf of a couple who allege their son’s heart defects were caused by the mother’s use of Zofran. According to the complaint, the boy was born with 3 separate congenital abnormalities — including a large atrial septal defect measuring 0.6 inches by 0.7 inches in size — that required him to undergo open heart surgery at the age of 4 years. The complaint marks the first of 40-odd Zofran heart defect lawsuits to specify the exact size hole in the patient’s heart.
Case #4:15-cv-01397-CDP – Filed September 10 on behalf of 4 women who allege prenatal exposure to Zofran caused their children to be born with severe congenital heart defects. Plaintiffs hail from Missouri, Delaware, North Carolina and Pennsylvania; their complaint was filed in the Circuit County of the City of St. Louis, Missouri.
Case #2:15cv-07134 – Filed September 28 in New Jersey Federal Court by a Virginia woman whose son was allegedly born with heart, lung and abdominal defects after being exposed to Zofran in the womb. According to the suit, plaintiff’s son was diagnosed with a Complete Atrioventricular Canal (CAVC), Doublet Outlet Right Ventricle (DORV), Heterotaxy of the Lungs and Malrotation of the Intestines. Complaint was transferred to the MDL on Oct. 23 under case number 15-13712.
September 29, 2015 – Lawsuit filed in San Francisco federal court by an Alameda County couple who claim Zofran caused their daughter to be born with severe congenital heart malformations which required open heart surgery. The complaint accuses GSK of negligence, misrepresentation, breach of warranty and violations of California law.
Case #1:15-cv-01734-CL – Oregon couple alleges Zofran exposure caused their son’s atrioventricular septal defect (AVSD). As a result of his defects “which will never completely resolve,” the boy required open-heart surgery at the age of 5 months, and is likely to require additional surgeries in the future, according to the lawsuit.
November 13, 2015 – Los Angeles residents Paul Ramirez and Dulce A. Morga file suit against GSK for injuries that led to the death of their daughter allegedly caused by Morga’s use of Zofran during pregnancy. According to the complaint, the couple’s child Sarah was born in late 2014 with severe congenital heart defects, including Epstein’s Anomaly. As a result of these problems, Sarah was forced to undergo open-heart surgery when she was just 5 days old. Sadly, she died from the trauma less than a week later.
Case #1:15-cv-13002-FDS – Lawsuit filed by Beth Botelho and Scott Mello alleging that Zofran exposure caused their daughter to be born with a serve congenital heart defect. Plaintiffs allege their daughter is small for her age and has problems at school, and that her long-term medical outlook is uncertain. Complaint was transferred to the MDL in Boston.
Case #1:16-cv-10544-FDA – Lawsuit filed by couple from Montegut, Louisiana, who claim their 2 daughters — born within a year of each other — were delivered with cardiac heart defects after being exposed to Zofran in the womb. The case (PDF) was initially filed March 3 in the U.S. District Court for the Eastern District of Louisiana, and has since been transferred to the Zofran MDL in Boston.
Do I Have a Zofran Heart Defect Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if your child was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.