Ondansetron, sold under the brand name Zofran, is a common anti-nausea drug. Some women are prescribed Zofran during pregnancy to combat morning sickness, which is one of the most common ailments facing pregnant women.
The Food and Drug Administration has not approved Zofran for the treatment of morning sickness. This is an off-label use that may carry serious risks, including the possibility of having a child with a birth defect, including cleft palates, atrial septal defects (ASD) and ventricular septal defects (VSD). The safety profile of Zofran, when taken by pregnant women, has not been thoroughly studied.
Studies have noted an apparent connection between Zofran and congenital birth defects. Women who take Zofran during the first trimester of pregnancy may be more than twice as likely to have a child suffering from certain defects, according to the studies.
Zofran May Double Heart Defect Risk
The studies that have found a connection between Zofran and birth defects come from reputable institutions both public and private, including the Harvard School of Public Health and the Centers for Disease Control and Prevention.
- A 2012 study found that women who took ondansetron in the first trimester of pregnancy were 2.37x more likely to have a child with a cleft palate than women not taking the drug.
- Women who took the drug in the first trimester of pregnancy were twice as likely to have a child with a heart defect, and 30 percent more like to have a birth defect overall, according to data presented in 2013 at the International Society of Pharmacoepidemiology.
- An Australian study found a 20% increased risk of a birth defect when a mother took Zofran in the first trimester.
- In 2006, a study in Hong Kong showed that Zofran crosses the human placenta in the first trimester of pregnancy. It was detected in 100% of the fetal tissue samples tested.
Additionally, news reports have identified this potential link. The Toronto Star reported in 2014 than an analysis of 2012 Canadian health records linked ondansetron with numerous adverse consequences, including:
- Two fetal deaths
- Fetal growth restriction in six infants
- A baby 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 an atrial septal defect, or a hole in the heart wall.
Help For Families Harmed by Zofran
Birth defects present families with a hardship they don’t deserve. They are tragic and, in some cases, life-threatening. They may require one or more surgeries to correct, and a child may deal with consequences from the condition for the rest of life.
If this has happened to your family, you deserve help. An experienced pharmaceutical drug lawyer at the Michael Brady Lynch Firm may be able to help your family get justice.
At our firm, we know how to go toe-to-toe with huge pharmaceutical companies like GlaxoSmithKline, the multibillion-dollar maker of Zofran. We’ve done it before and have been successful on behalf of families like yours. We don’t back down, and we don’t stop until we’ve pursued every possible angle to get your family compensated for what you’ve been put through.
We may be able to seek compensation for:
- Hospital stays and medical procedures
- Future care
- The pain and suffering this brought on your family
Contact the Michael Brady Lynch Firm
If you took Zofran during pregnancy and gave birth to a child with a congenital defect, we want to hear from you. We may be able to build a case seeking compensation on your behalf.
A case evaluation is free, and there is never any obligation on your part. Let us tell you what we can do for you. Our job is to make things as easy as possible for our clients during this difficult time.
Call us today or fill out the form on this page to speak with us. We may be able to fight for a better future for your family.