Women who take the anti-nausea drug Zofran (generic: ondansetron) during pregnancy may have an increased risk of giving birth to babies with severe malformations such as an atrial septal defect (ASD).
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with an atrial septal 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 against the manufacturer and our lawyers can help.
Update: Zofran Lawsuit ‘Short Form Complaint’ Speeds Up Filing Process
July 6, 2016 – In one of the first lawsuits to be filed using the new “Short Form Complaint,” a mother from Sandusky, Ohio claims her son was born with an atrial septal defect, ventricular septal defect and cleft palate after being exposed to Zofran in the womb. The mother also claims her child has suffered “issues with vision and hearing,” likely as a result of her cleft palate. The complaint was filed June 24, 2016 under case number 1:16-cv-11281-FDS.
Zofran is an anti-nausea medication that blocks the actions of chemicals that can trigger nausea and vomiting. The drug is indicated for the treatment of these conditions when caused by surgery or cancer medication. Zofran is manufactured by GlaxoSmithKline (GSK), and was approved by the U.S. Food & Drug Administration (FDA) in 1991.
What’s the Problem?
Although not approved for this use, Zofran is commonly prescribed “off-label” for the treatment of nausea and vomiting associated with morning sickness. Off-label prescribing is legal and done at the doctor’s discretion; however, when prescribed in this capacity, Zofran has been linked to birth defects.
Zofran Heart Defect Study
A 2013 Danish Study titled “Ondansetron use in early pregnancy and the risk of congenital malformations” found that women who used Zofran during their 1st trimester of pregnancy were twice as likely to give birth to babies with congenital heart defects compared to pregnant women who did not take the drug.
The study’s cohort included all women who had babies in Denmark from 1997 to 2010. The primary outcome was the prevalence of major congenital birth defects according to the EUROCAT classification system, with specific subgrouping among 1st trimester Zofran users compared to non-users. Exposure was defined in women who filled at least 1 prescription for Zofran during their 1st trimester.
The researchers identified 897,018 Danish births between 1997 and 2010. During this period, 1,248 pregnant women filled a Zofran prescription during their 1st trimester. Of these, 58 (4.7%) gave birth to babies with severe congenital malformations compared to 3.5% of the 31,357 women who did not take Zofran in pregnancy.
Most of the defects identified by the study were coronary artery abnormalities such as atrial septal defects. “We found a doubling in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription of ondansetron in the first trimester of pregnancy,” the authors concluded.
What is an Atrial Septal Defect?
An atrial septal defect, or ASD, is a congenital (present at birth) abnormality characterized by a hole in the upper 2 chambers of the heart (atria). As a baby develops in the womb, a wall called the interatrial septum forms which divides the upper chamber into a left and right atrium. An abnormal formation of the interatrial septum may result in a hole, or atrial septal defect.
Signs and symptoms of an atrial septal defect may include:
- Difficulty breathing (dyspnea)
- Respiratory infections
- Heart palpitations
- Shortness of breath with activity
Atrial septal defects may not require treatment in patients who are asymptomatic, or who have minor symptoms. Surgery to close the ASD may be recommended if the hole causes a large amount of shunting, the heart is swollen, or other symptoms occur.
In recent years, a procedure has been developed to close an atrial septal defect without surgery. The procedure involves placing a closure device into the heart through catheters. The physician makes a small incision in the groin, then inserts the catheters into a blood vessel and up into the heart. The closure device is then placed across the defect and the hole is closed.
Tennessee Mother Alleges Zofran Caused Daughter’s Atrial Septal Defect
February 9, 2016 – A woman from Tennessee whose daughter was allegedly born with heart defects including pulmonary valve stenosis an atrial septal defect after being exposed to Zofran in the womb has filed a product liability lawsuit against GSK. Plaintiff claims that neither she nor anyone else in her family has a history of congenital heart defects; additionally, says she had an earlier pregnancy in which she did not take Zofran and gave birth to a healthy baby girl.
Kansas Woman Blames Zofran for Daughter’s ASD
November 18, 2015 – A mother from Kansas has filed a lawsuit against GSK alleging that her use of Zofran for morning sickness caused her daughter to be born with an atrial septal defect. The woman accuses GSK of failing to warn about the risks associated with taking Zofran during pregnancy. Click here to learn more.
Louisiana Mother Claims Zofran Exposure Led to Atrial Septal Defect
June 8, 2015 – A Louisiana mother filed a lawsuit against GSK today alleging that her use of Zofran during pregnancy caused her daughter to be born with an atrial septal defect, ventricular septal defect and intermittent tachypnea. According to the complaint, plaintiff’s baby required open heart surgery to correct the defects. Click here to learn more.
Zofran Atrial Septal Defects Lawsuit Filed in Minnesota
A Minnesota woman whose 2 children were born with atrial septal defects after she took Zofran in pregnancy has filed a lawsuit against GSK. The woman claims she was never warned that Zofran had not been approved to treat morning sickness, and that the manufacturer should be held liable for her children’s birth defects. Click here to learn more.
Alabama Couple Alleges Son’s Heart Defects Caused by Zofran
September 8 – Complaint filed today in the U.S. District Court for the Northern District of Alabama, Southern Division, on behalf of a couple whose son was allegedly born with 3 separate congenital heart defects — including a large ASD measuring 0.6 inches by 0.7 inches in size — after the mother took Zofran for morning sickness in the early part of her pregnancy. The case marks the first of 40-odd Zofran heart defect lawsuits to specify the exact size hole in the patient’s heart. The complaint was filed under case number 2:15-cv-01638-RDP.
Zofran During Pregnancy Injured Baby, Mother Says
On September 29, the parents of a child born with an atrial septal defect filed a lawsuit against GSK for promoting the use of Zofran for morning sickness. Since their daughter’s birth in 2007, she has had to undergo surgery and multiple invasive treatments including cardiac catheterization and placement of a septal occlude to correct the ASD, according to the complaint. To support their allegations, the parents claim that neither side has a history of congenital heart defects, so there is likely no genetic cause for their daughter’s heart problem.
Do I Have a Zofran Atrial Septal 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 or other loved one was born with an atrial septal defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.