New evidence reveals that Zofran, a popular anti-nausea medication sometimes used to treat morning sickness, may cause birth defects and other devastating side effects that are not listed on the drug’s label.
Many pregnant women were prescribed Zofran to reduce the effects of morning sickness, but this off-label use was not approved by the U.S. Food and Drug Administration. As a result, unborn babies may have unknowingly been exposed to an increased risk for severe birth defects. Our lawyers have been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fatal injuries including cleft palate, lip and congenital heart defects.
How Does Zofran Work?
Zofran (ondansetron) blocks the actions of chemicals that produce the feeling of nausea in people who are undergoing surgery or chemotherapy. It is a 5-HT3 antagonist that primarily acts on the nervous system. Zofran blocks serotonin production and increases the rate gastric emptying, which can alleviate the sensation of nausea.
It is not approved for use as a morning sickness drug, however some doctors prescribe it for that very reason. This is despite recent studies which indicate it comes with serious side effects to both mother and infant. Zofran is marketed and sold by GlaxoSmithKline and was approved by the FDA in 1991. It’s important to note that despite its potential risks, the FDA has not stopped Zofran from being prescribed. However, doctors have the legal duty to inform all pregnant women of the risks associated with Zofran prior to prescribing it.
U.S. Department of Justice Accuses GlaxoSmithKline of Fraud
In 2012, the U.S. Department of Justice (DOJ) accused Zofran manufacturer GlaxoSmithKline of using illegal tactics to market Zofran for off-label uses, like the treatment of morning sickness in pregnant women. The DOJ further alleged that doctors who prescribed it for such use received kickbacks from the drug maker.
GlaxoSmithKline paid $3 billion to the DOJ to settle these charges. Current lawsuits made by patients who were prescribed Zofran carry similar allegations.
Pregnancy Risks Linked to Zofran
Pregnant women who were instructed to take Zofran may have unknowingly exposed their fetus to a number of birth defects, including:
- Cleft lip or palate
- Heart defects
- Kidney defects
- Inhibited fetal growth
- Limb deformities
- Congenital heart defect
We believe there is now strong evidence that Zofran (ondansetron) may be the cause of these defects.