According to a recent Zofran research study, the popular anti-nausea medication regularly prescribed to treat morning sickness may increase a pregnant mother’s risk of having a child born with birth defects.

Zofran (also known as ondansetron) is an anti-nausea drug manufactured and sold by the pharmaceutical company GlaxoSmithKline (GSK). Originally, Zofran was given FDA approval in 1991 as a nausea and vomiting treatment available to patients of chemotherapy. Because of its anti-nausea properties, many doctors have made a practice of prescribing Zofran “off-label” to help pregnant mothers manage morning sickness symptoms, even though it has not been approved for this specific use.

However, in light of new Zofran research and several consumer claims, many  individuals have filed or will decide to file Zofran birth defect lawsuits, alleging GSK did not warn the medical community and expecting mothers of Zofran pregnancy use and the increased risk of serious fetal harm and birth defects.

This is not the first time that Zofran’s manufacturer has met legal problems concerning their anti-nausea medication. In 2012, GlaxoSmithKline settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Zofran Pregnancy Research Studies

A number of Zofran birth defects research studies have been conducted within the United States and abroad, all similarly concerned with the potential side effects of taking Zofran while pregnant, especially during the first trimester when morning sickness is typically the worst and when birth defects are most likely to develop.

In one Danish Zofran pregnancy study published in 2013, 600,000 births were reviewed and found no significant increased risk of Zofran birth defects. However, six months later a similar study was performed using the same original data, but with an additional 300,000 births and allegedly found that there existed a 30 percent increased risk of birth defects overall when taking Zofran, including a doubled risk of Zofran heart defects.

According to research studies and medical reports, some potential Zofran birth defects include:

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

Additionally, a 2012 research study conducted by the Center for National Birth Defects Research and Prevention found that cleft lip and cleft palate birth defects were increased 2.4 times when a mother ingested Zofran during the first trimester.

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 pregnancy side effects are not just limited to the baby in the mother’s womb, as there have been reports of Zofran maternal risks as well. Zofran pregnancy side effects are especially prevalent in women with electrolyte imbalances that is often caused by severe nausea and vomiting. These Zofran risks for mothers include Serotonin Syndrome, rapid heart rate, high blood pressure, diarrhea, and other potential Zofran side effects.

Zofran’s drug labels allegedly do not include risks of Zofran birth defects, meaning that GSK could be liable for negligent manufacturing, selling, and marketing of a drug. Many mothers may choose to pursue a Zofran birth defects lawsuit or join a Zofran birth defects class action lawsuit.