Zofran birth defect lawsuits have been filed, accusing GlaxoSmithKline of marketing a drug to pregnant women when it had not been approved for use during pregnancy.

Zofran has reportedly been prescribed, off-label, to pregnant women who suffer from a severe morning sickness called hyperemesis gravidarum. It was originally approved by the U.S. Food and Drug Administration (FDA) in 1991 as a way to treat patients who have experienced nausea and/or vomiting during surgery or chemotherapy.

Despite the widespread use of Zofran in pregnant women, there are currently no warnings about potential Zofran birth defects. Zofran birth defect lawsuits have included claims of negligence, failure to warn, and illegal marketing.

Zofran Birth Defect Information and Studies

The Zofran generic, ondansetron, was categorized into Pregnancy Category B. This means that animal studies had no evidence of pregnancy risk and that any human studies performed were inadequate. At the time, the ondansetron categorization was based on less than 200 cases. However, Zofran studies have since discovered that Zofran use, especially during the first trimester, may lead to serious birth defects.

Several studies have been performed that have strongly indicated that Zofran, though perhaps effective at treating morning sickness, can cause serious birth defects. One Danish study initially found that there was not an increase of birth defects in infants whose mothers used Zofran. A few months later, another study expanded the number of cases from 600,000 to 900,000. Using the same cases, they found that there was a 30 percent increased chance of Zofran birth defects among Zofran users, especially for heart defects.

Several women have reported adverse side effects to the FDA concerning serious birth defects which were allegedly not warned about on Zofran’s warning label.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Birth Defects

Potential Zofran birth defects may include:

• Cleft lip and cleft palate (2.4-fold increased risk)
• Heart defects (doubled risk)
• Kidney defects
• Musculoskeletal defects
• Poor fetal growth

These Zofran birth defects will most likely impact the entirety of the infant’s life and may require expensive medical treatment in addition to pain and suffering experienced by the infant and parents.

Zofran may also negatively affect pregnant women and cause them to experience cognitive or behavioral side effects in addition to an increased heart rate and blood pressure, diarrhea, and additional side effects associated with Serotonin Syndrome.

Zofran birth defect lawsuits have claimed that GlaxoSmithKline promoted and sold its anti-nausea medication to pregnant women without warning them about the potential Zofran birth defects that might follow.

This is especially troubling considering that most women need morning sickness medication during the first trimester, when the risk of developing Zofran birth defects is at its highest. Other drug manufacturers have been held legally responsible for off-label promotion and have paid plaintiffs millions of dollars in compensation.