Zofran Lawsuits | Birth Defects

If you or a loved one has taken Zofran for morning sickness during pregnancy and your baby suffered birth defects, you may be eligible to file a Zofran lawsuit.

In 1991, GlaxoSmithKline (GSK), a London-based pharmaceutical company, introduced Zofran (ondansetron). Zofran is an anti-nausea prescription medication that was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients undergoing surgery, chemotherapy, and radiation.

Over the past decade, Zofran has been heavily marketed and prescribed “off-label” — not approved by the FDA — for the treatment of severe morning sickness. By 2013, it was being used by 1 million pregnant women per year.

A growing number of medical studies are showing that Zofran increases the risk of birth defects when taken by expectant mothers during the first trimester of pregnancy.

What Is Zofran?

Zofran was approved by the FDA to help manage nausea and vomiting in surgery, chemotherapy and radiation patients. The drug is a 5-HT3 antagonist that primarily acts on the nervous system. It works by blocking serotonin and increasing gastric emptying, which helps reduce nausea and vomiting.

Pregnancy Risks And Birth Defects Linked To Zofran Use

Taking Zofran while pregnant can potentially lead to serious birth defects. Additionally, because morning sickness typically occurs in the first trimester, women are taking Zofran during a period of time that is critical to the development of the fetus.

The most common risks and birth defects associated with Zofran use during pregnancy include:

  • Birth defects
  • Atrial septal defect (hole in the heart)
  • Heart defects
  • Heart murmur
  • Cleft palate
  • Cleft lip
  • Fetal growth restriction (poor growth in the womb)
  • Kidney defect
  • Serotonin syndrome
  • Jaundice
  • Life-threatening pregnancy complications
  • Death

Zofran Studies

A study by the National Center for Biotechnology Information found that taking Zofran during pregnancy could double the chances of a baby being born with a cleft palate.

In August 2013, researchers in a Danish study found a two-fold increase in cardiovascular defects in children whose mothers took Zofran during their first trimester of pregnancy.

The study analyzed data from more than 900,000 pregnant women over a 13-year period. The study found that there is a 4.7 percent chance that women taking Zofran during their first trimester will give birth to a baby with congenital abnormalities, an increase in the occurrence of more than 30 percent when compared with women who did not take Zofran during their first trimester.

On June 25, 2014, the Toronto Star reported on the link between Zofran use during pregnancy and birth defects. The Star analyzed submissions to the FDA’s public side-effect database in 2012 from women who had been given an off-label prescription of Zofran to treat vomiting during pregnancy.

The Star found that these women gave birth to children who suffered from various birth defects, including kidney malformations and heart defects. The Star’s investigation also uncovered two reports of infant deaths that are potentially linked to their mothers’ use of Zofran.

GlaxoSmithKline Settles For $3 Billion In Whistleblower Lawsuit

GSK is one of the largest pharmaceutical companies in the world. The company has been the defendant in several whistleblower lawsuits alleging both illegal marketing practices and kickbacks to prescribing doctors.

In July 2012, GlaxoSmithKline agreed to a $3 billion settlement for the illegal promotion of several prescription medications, as well as other violations of federal law. This included resolving allegations that the company promoted Zofran for “off-label” use for pregnant women with morning sickness.

Free Consultation: Contact Us Today

If you or a loved one has taken Zofran for morning sickness during pregnancy and your baby suffered birth defects, you may be eligible to file a Zofran lawsuit.

Give us a call toll-free at 916-461-8492  or request a free consultation online.

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