More than 200 Zofran lawsuit plaintiffs have accused GlaxoSmithKline of failing to warn expectant mothers and doctors that use of the anti-nausea drug during pregnancy might harm an unborn baby. Now these same plaintiffs are questioning why Zofran’s Canadian label includes stronger pregnancy warnings compared to those provided to patients and doctors here in the U.S.

Canadian Zofran Label Modified in 2015

The U.S. Food & Drug Administration (FDA) has not approved Zofran to treat pregnancy-related nausea and vomiting, yet the medication has long been prescribed for this purpose.  According to, the FDA has placed Zofran in Pregnancy Category B. The U.S. label currently states: “Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”

Since April 2015, the Canadian Zofran label has cautioned that “the safety of ondansetron for use in human pregnancy has not been established,” and “use in pregnancy is not recommended.” The label was modified nearly a year after a Toronto Star investigation revealed that 20 Canadian women had experienced serious complications after they were prescribed Zofran to alleviate morning sickness. Those adverse events included two infant deaths and numerous reports of heart birth defects and kidney malformations.

Zofran Lawsuit Reviews

At least 247 Zofran lawsuits have been filed in federal court on behalf of children who allegedly developed serious birth defects after their mothers took the medication during the first trimester of pregnancy. All of the lawsuits claim that GlaxoSmithKline concealed evidence linking Zofran to birth defects, and accuse the company of aggressively marketing the drug as a safe and effective treatment for morning sickness.

Bernstein Liebhard LLP continues to investigate Zofran birth defects claims. If you believe that your child was harmed by Zofran, please contact our office today at 877-779-1414 to arrange for a free legal review.

Published April 26, 2016 by