Multiple Case Studies Linking Zofran and Birth Defects

April 2, 2015–Several studies have begun in order to establish a link between the drug ondansetron, which is marketed by GlaxoSmithKline as Zofran, and major birth defects. The drug has been frequently prescribed to pregnant women for severe morning sickness. Since Zofran is originally intended for chemotherapy patients, the FDA never approved it for this off-label use. The manufacturer, GlaxoSmithKline, continues to deny any unlawful promotion of the drug, even with the negative studies unfolding around Zofran.

GlaxoSmithKline has not tested Zofran’s effects for morning sickness and has presented no evidence that the drug is safe for unborn babies. Several epidemiological studies have shown the opposite. Multiple teams of researchers have noted a marked increase in the likelihood of birth defects among women exposed to Zofran during early pregnancy.

Zofran Case Studies Around the World

United States

Researchers from Harvard University and Boston University’s Slone Epidemiology Center worked in association with US Centers for Disease Control and reviewed data pertaining to over 10,000 births. While most of the pregnant women experienced nausea and vomiting, only 15.4% reported being prescribed Zofran or its generic equivalent. The conclusion of the study found that women who had taken Zofran had an increased risk of birth defects.

In early 2015, two patients that showed signs of gastroenteritis, or the stomach flu, were treated with doses of ondansetron, which led to the patients experiencing abnormally fast heartbeats. Unfortunately, both patients eventually died from failed resuscitation efforts. The pediatric patients were a 10 year old boy and an 86-day-old infant. Ondansetron, or Zofran, is often used off-label to treat the vomiting that the stomach flu can cause.


Using birth records from 1998 to 2012, Swedish researchers identified 1,349 children born to women exposed to Zofran during pregnancy. When compared to women who were not exposed to the drug, the mothers who took Zofran were 1.62 times more likely to give birth to babies cardiac septum defects, which are congenital heart defects.


Researchers collected data of all births in Australia between 2002-2005, which included around 95,000 births in total. Only a small percentage, 0.25%, of women studied had taken Zofran during their pregnancy. Despite this percentage, the study showed that women prescribed Zofran in the first trimester were 20% more likely to deliver babies with major birth defects. In addition, children delivered by women taking Zofran were reported to be around six times more likely to develop rare kidney defects.

What does GlaxoSmithKline say?

In 2012, GlaxoSmithKline denied the Department of Justice’s claims that Zofran was unlawfully marketed to OB/GYNs. While the company is against any and all accusations of wrongdoing, it did settle the DOJ’s case for a whopping $3 billion. More recently, lawsuits are going even deeper, claiming the company knew of Zofran’s potential risks for fetal development, yet did nothing to warn the health community or public.

If you, or someone you love, has been effected by Zofran, it’s not your fault. It’s the manufacturer’s responsibility to give doctors all of the information about the drugs they are prescribing, and GlaxoSmithKline has been accused of neglecting to do so. Don’t let drug companies get away with unlawful marketing.


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Sources: BioMedSearch, NCBI, Pediatric Emergency Care