A growing number of consumers allege GlaxoSmithKline knew, or should have reasonably known, for years about the risk of Zofran birth defects when expectant mothers used Zofran as a morning sickness or hyperemesis gravidarum treatment.

The FDA has only approved Zofran (ondansetron) as a nausea and vomit treatment for patients undergoing surgery or battling cancer. However, many doctors have taken to prescribing Zofran off-label to pregnant women to combat nausea and intense morning sickness. Prescriptions for Zofran during pregnancy have accounted for a majority of Zofran annual sales for the past decade.

For many years, the medical community assumed the use of Zofran while pregnant was a safe nausea treatment option. However, a number of studies in recent years suggest Zofran could cause a fetus to develop birth defects, especially if the mother takes this anti-nausea drug during the first trimester of her pregnancy.

In the face of this research and several consumer reports, GlaxoKlineSmith is now facing several Zofran birth defects lawsuits and possible class action lawsuits filed by parents nationwide on behalf of their children, alleging the pharmaceutical company withheld important information regarding Zofran side effects from women and the medical community.

Zofran Pregnancy Research Studies

A number of Zofran birth defects studies have been conducted in different countries, looking at the potential side effects of taking Zofran while pregnant. One of the earliest studies regarding Zofran side effects studies for pregnant women was conducted in 2006 by Hong Kong researchers, who reported that significant amounts of Zofran pass into the placenta when taken by a pregnant woman.

While worrisome, “researchers concluded that the developmental significance of this drug exposure requires further investigation.” Since then, several other Zofran research studies have been conducted and resulted in similar birth defects risks.

In a 2013 Zofran pregnancy study conducted in Denmark, a total of 900,000 births were reviewed in order to study the prevalence of Zofran birth defects. This Zofran birth defects study concluded that mothers who took Zofran while pregnant were at a 30 percent increased risk of giving birth to infants with several types of birth defects. This Danish birth defects study also noted a doubled risk of Zofran heart defects.

Some potential Zofran birth defects reported in various studies include:

• Cleft lip
• Cleft palate
• Heart defects
• Kidney defects
• Musculoskeletal defects
• Decreased  fetal growth
• Fetal death

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.”

Many parents may choose to pursue Zofran birth defects lawsuits or join a Zofran birth defects class action lawsuit in order to gain compensation for the pain and suffering experienced by their children in relation to the alleged birth defects. Additionally, many of these proposed Zofran lawsuits are seeking payback for the financial hardships of treating and managing these Zofran birth defects.