Women who use Zofran to treat morning sickness during pregnancy may be twice as likely to have a baby with a heart defect, cleft palate, or other defects, according to several recent studies.
Zofran (ondansetron) is a powerful anti-nausea drug that is approved to treat chemotherapy and surgery patients. It was approved by the FDA in 1991 and is marketed by GlaxoSmithKline.
Zofran and Birth Defects
Zofran is not approved for use during pregnancy. It is a “Pregnancy Category B” medication, which means its risks to a fetus are unknown. Its safety during pregnancy was based on fewer than 200 births.
In the last few years, a number of studies have raised alarm that Zofran may increase the risk of birth defects:
- In 2012, a large study by the Sloan epidemiology unit and the Centers for Disease Control (CDC) linked the use of Zofran in the first trimester of pregnancy with a 2.4-fold increased risk of cleft palate
- Six months after this study involving 600,000 births found no evidence linking Zofran and birth defects, another study based on 900,000 births from the same registry linked Zofran with a 30% increased risk of birth defects overall, and a doubled risk of heart defects.
- In December 2013, a study published by Australian researchers linked the use of Zofran in the first trimester with a 20% increased risk of birth defects, though the estimate was imprecise and based on a small sample size. Researchers also found a higher rate of kidney defects, described as “obstructive defects of renal pelvis and ureter,” such as hydronephrosis.
- In December 2014, Swedish researchers published a study in Reproductive Toxicology linking Zofran with a doubled risk of septal heart defects (also known as “hole in the heart” defects) based on data from 1,400 babies exposed to Zofran in the 1st trimester.
More recently, an investigative report published in June 2014 by the Toronto Star found at least 20 case reports linking Zofran and birth defects, including two fetal deaths, multiple heart defects, kidney defects, musculoskeletal defects, and poor fetal growth. Click here to read more.
Maternal Safety Risks
The FDA is also investigating two side effects of Zofran that could jeopardize maternal safety, including serotonin syndrome and irregular heart rhythm that could lead to deadly cardiovascular events.
Unfortunately, this is not the first time a morning sickness drug has been linked to birth defects. Thalidomide, a drug that was marketed in the 1950s and 60s, caused over 10,000 babies to be born with very serious limb malformations.
What is the problem?
The Schmidt Firm, PLLC is nationally recognized as a class action law firm. However, our attorneys are not currently filing a Zofran class action. Instead, we are only filing individual lawsuits involving birth defects caused by Zofran.
Contact us if your child was injured by:
- Birth defects
- Heart defects
- Heart murmur
- Atrial septal defect
- Ventricular septal defect
- Hole in the heart
- Cleft lip
- Cleft palate
- Musculoskeletal Defects
- Fetal growth restriction (poor growth in the womb)
- Kidney defects
- And more