Pregnant women who use Zofran to treat morning sickness in the first trimester may be putting their baby’s health in danger. Recent studies have linked Zofran to a 30% increased risk of birth defects, a doubled risk of heart defects and cleft palate, and other pregnancy risks.
Free Zofran Lawsuit Information: If you or somebody you know had a baby with a birth defect, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
Zofran (ondansetron) was approved by the FDA in 1991 for the treatment of the most severe nausea imaginable — that associated with chemotherapy. At the time, there was no FDA-approved drug for treating nausea associated with pregnancy. Zofran quickly became a popular “off-label” (unapproved) drug for morning sickness.
Is Zofran Safe to Use During Pregnancy?
Zofran is not approved for use during pregnancy. Yet every year, about 1 million pregnant women use Zofran to treat morning sickness during the first trimester. These women believe Zofran is safe. In reality, Zofran is a “Pregnancy Category B” drug, its fetal safety is unknown (based on fewer than 200 births), and there is growing evidence that it poses life-threatening risks to a developing baby.
Zofran Birth Defects
Our attorneys are investigating potential lawsuits involving:
- Birth defects
- Heart defects
- Heart murmur
- Atrial septal defect (“hole in the heart”)
- Cleft lip
- Cleft palate
- Fetal growth restriction (poor growth in the womb)
- Kidney defects (hydronephrosis)
- Life-threatening pregnancy complications
Studies Linking Zofran and Birth Defects
- Zofran was associated with a 2.4-fold increased risk of cleft palate in a study published in Birth Defects Research in 2012, based on data from 9,000 pregnancies.
- Zofran was linked to a 30% increased risk of major birth defects and a doubled risk of heart defects in a study by Dr. Jon T. Andersen, based on data from 900,000 pregnancies in Denmark between 1997-2010. Out of nearly 1,300 women who used Zofran in the first trimester, 4.7% had a baby with a birth defect.
- Zofran was associated with a doubled risk of “hole in the heart” defects in a study conducted by Swedish researchers, based on 1,400 pregnancies where it was used in the first trimester.
- Zofran was associated with to a 20% increased risk of birth defects and even higher rates of kidney defects in a study published by Australian researchers, but the results were imprecise and based on small sample sizes.
- In June 2014, the Toronto Star published an investigation linking Zofran with 20 reports of birth defects, including heart defects, fetal growth restriction, kidney defects, musculoskeletal abnormalities, fetal death, and more.
What Is the Alternative?
After 30 years without another drug for morning sickness, the FDA approved Diclegis (pyridoxine and doxylamine). Diclegis is a “Pregnancy Category A” drug that combines Vitamin B6 with an antihistamine.
The formula has been used for morning sickness since the 1950s, but was pulled off the market in 1983 over fears of causing birth defects. The FDA re-approved it after studies involving 250,000 pregnancies found no evidence of any risk to a developing baby.
Experts now agree that doctors should change the way they prescribe drugs for morning sickness. According recommendations from Dr. Gideon Koren of the Motherisk Program:
“Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.”
Maternal Safety Concerns
Zofran also poses serious risks to a pregnant women. The FDA has issued warnings about heart rhythm disorders, which could be more serious for pregnant women suffering from electrolyte imbalances due to severe nausea and vomiting.
The FDA has also issued warnings about serotonin syndrome, another side effect that could be more serious in pregnant women who are taking SSRI antidepressants.
Moms File 1st Zofran Birth Defect Lawsuits
In February 2015, GSK was hit wit