Zofran, also known as ondansetron and Zuplenz, is an anti-nausea medication approved for use for cancer and surgery patients. Yet, it’s been prescribed by doctors across the nation as off-label use for morning sickness for numerous years. In turn, many babies were born with mild to serious birth defects, which according to scientific studies, may have been associated with mothers taking Zofran while pregnant.
Types of Birth Defects Associated With Zofran Use
Unfortunately, a myriad of birth defects have been linked to Zofran use during pregnancy. While some birth defects are considered more mild than others, any kind of birth defect impacts parents and babies alike. The following birth defects are currently associated with Zofran. However, as more studies are done on the relationship between the medication and pregnancy, the following list may increase:
- Cleft lip and cleft palate
- Heart defects and abnormalities
- Musculoskeletal anomalies and skull deformities
- Neural tube defect, including spina bifida
- Sensitivity to light
- Developmental delays
- Hearing problems
- Cerebral palsy
Dr. Gideon Koren’s Study on Zofran and Pregnancy
Dr. Gideon Koren, a Canadian pediatrician, performed an in-depth study on Zofran use during pregnancy. The results, published after Dr. Koren studied a total of 176 pregnant women who took Zofran throughout 2004, showed an overwhelming correlation between a heightened risk of birth defects associated with taking the drug during pregnancy.
According to the study, women who take Zofran while pregnant have a fivefold increased risk of having babies with major malformations, although specific malformations were not mentioned. In his study, Koren wrote that,
“There is no reason for women to be exposed to a drug of unproven maternal and fetal safety when there are safer options currently available.”
After Dr. Koren’s study became available, numerous other studies were performed, which provided additional in-depth information on the risks of taking Zofran during pregnancy, including:
FDA Warning on Zofran Use During Pregnancy
In 2012, the FDA issued a warning on using Zofran during pregnancy, followed by an updated 2013 warning that indicates that Zofran may potentially cause abnormal and fatal heart rhythms, known as Torsade de Pointes.
National Birth Defects Prevention Study on Zofran and Pregnancy
In 2012, the Slone Epidemiology Center at Boston University and the National Birth Defects Prevention Study released the results of a study in which numerous anti-nausea medications were researched in order to find a connection between birth defects and the drugs used during pregnancy.
According to the study, taking Zofran during pregnancy poses a heightened twofold risk of babies developing a cleft palate (CP).
Danish Registry Study on Zofran and Pregnancy
In 2013, a study performed on 900,000 Danish women who took Zofran while pregnant indicated that if the medication is taken during pregnancy, there is a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”
GlaxoSmithKline (GSK), the makers of Zofran, is currently facing many Zofran lawsuits due to the high rate of infants born with birth defects. If you took Zofran while pregnant, keep in mind that you have the legal right to file against the responsible party. Birth defects can result in extremely costly medical bills and a host of other issues. You may be entitled to compensation for medical expenses, lost wages, pain, suffering, and more.