Zofran has been marketed as a safe and effective medication to treat nausea and vomiting for cancer chemotherapy, and doctors have been encouraged to prescribe it off-label to pregnant women as a morning sickness medication during the first trimester.

Unfortunately, Zofran side effects may be linked to serious birth defects, including musculoskeletal anomalies, intrauterine growth restriction, cleft palate, heart murmurs, kidney malformations, jaundice, and death.

In all of these cases, Zofran was prescribed off-label to pregnant women when there was no evidence it was safe during pregnancy.

Many of these women who had babies born with Zofran-related birth defects along with their families may have been led to believe that they were not eligible to file a legal claim due to statute of limitation laws.

But according to a Consumer Safety Watch report, these statute of limitations are mute since the drug maker GlaxoSmithKline (GSK) has failed to acknowledge that Zofran side effects may cause birth defects.

Risks of Zofran Use in Pregnancy

Zofran (ondansetron) is a popular anti-nausea medication approved by the U.S. Food and Drug Administration (FDA) as a treatment for nausea and vomiting in cancer patients undergoing chemotherapy.

However, Zofran is often prescribed off-label to pregnant women suffering from morning sickness, despite the fact that the anti-nausea drug has never been FDA-approved for this use.

As a result, more than one million pregnant women are prescribed Zofran as a morning sickness medication every year.

Zofran Side Effects Study

One of the first Zofran birth defect studies was published in the medical journal BJOG in September 2004, and researchers involved in the study highlighted case reports linking Zofran side effects to an increased risk of genital birth defects in babies, although GSK never investigated this alleged risk.

In the years since, a number of studies have examined the potential connection between Zofran side effects and congenital malformations, including a December 2014 study that found a two-fold increased risk of “hole in the heart” birth defects, and a 62% increased risk of heart birth defects in general, associated with Zofran use in pregnancy.

No Clear Statute of Limitations

In legal terms, “statute of limitation” is the time period in which a person is able to file a lawsuit after suffering an injury, usually lasting a certain number of years after the person discovered or reasonably should have discovered what caused the injury.

In regards to birth defects from Zofran however, there is no clear statute of limitation for lawsuits to be filed, as most parents of older children are just now discovering that Zofran is capable of crossing the human placenta and causing birth defects when taken during pregnancy.

In fact, much of the research linking Zofran side effects to birth defects like cleft lip, cleft palate, heart malformations and kidney defects has just recently been made public.

Zofran lawsuits claim that patients were never given the opportunity to know of the potential dangers linked to Zofran side effects until recently, therefore the statute of limitations does not apply.

Expert Zofran birth defect attorneys are encouraging the families of children with Zofran-related birth defects such as cleft or heart defects born in 2007 or earlier to speak to a qualified birth defect lawyer about possibly bringing a claim against GlaxoSmithKline, as there is no clear statute of limitation for Zofran birth defect lawsuits to be filed.

In other words, a lawsuit against GSK may be possible even for children born years ago. In fact, some Zofran lawsuits even involve children born a decade ago.