Last year, a Canadian newspaper and other sources reported that Zofran, an anti-nausea prescription medication not approved by the Canadian government for morning sickness, has been linked with an increased risk of birth defects.

According to news reports, Health Canada has only approved Zofran (also known as ondansetron) as an anti-nausea treatment for patients undergoing chemotherapy. However, it seems that in Canada, as well as within the United States, many doctors have been pushed to prescribe Zofran for off-label use, namely to combat the side effects of morning sickness most women experience during the first trimester of pregnancy. It has been found to be especially helpful for women have hyperemesis gravidarum, an extreme form of morning sickness.

However, according to studies conducted by the U.S. Food and Drug Administration (FDA), the agency found that at least 20 Canadian women who were treated with Zofran or a generic version of the brand-name prescription drug during their pregnancy to manage morning sickness reportedly experienced Zofran side effects. In fact, two infant deaths and multiple cases of Canadian-born babies exhibited kidney and heart defects that can allegedly be attributed to the mother’s use of Zofran during the pregnancy.

Furthermore, Canadian news sources claim that according to the FDA documents, four of the Canadian babies studied were underweight when born, some weighing as little as four-and-a-half pounds. Because of these and other cases, researchers have suggested that Zofran manufacturers add fetal growth restriction as a possible Zofran pregnancy side effect.

All the Canadian-specific data collected by the FDA and used in this Zofran birth defects report were filed by Canadian health-professionals to the American agency between 2010 and 2013. The FDA’s Zofran birth defects findings and other similar studies questioning the safety of taking Zofran while pregnant have surfaced over the last few years, contradicting an earlier Zofran research study published in the New England Journal of Medicine, which claimed ondansetron drugs were safe for growing fetuses.

Zofran Pregnancy Research Studies

Numerous Zofran birth defects research studies have been conducted within the United States and abroad, studying the potential side effects of taking Zofran while pregnant, especially during the first trimester when morning sickness is likely to hit hardest.

According to 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 among pregnant Danish mothers, contradicting another Danish study performed 6 months prior, which found there was no significant difference in birth defect risks between mothers who took Zofran and those who didn’t during pregnancy. According to this Zofran pregnancy side effects study, scientists 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.

Some potential Zofran birth defects reported in various Zofran 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.”

Zofran’s drug labels allegedly do not include risks of Zofran birth defects, meaning that the drug’s manufacturer 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.