Zofran Labeled with Warning of Use During Pregnancy In Canada, but Not in United States

Posted on June 16, 2016

The United States Department of Justice accused GlaxoSmithKline (GSK) of illegally marketing Zofran to pregnant women as a remedy for morning sickness earlier in this decade. The U.S. Food and Drug Administration (FDA) has not approved Zofran for this purpose. Zofran (ondansetron) has been linked to birth defects in children born to women who were prescribed the medication during pregnancy. In 2012, GSK agreed to pay a settlement but did not amend the product’s label to clarify its intended and approved use: to treat nausea and vomiting resulting from chemotherapy or surgery.

The prescription guidelines for Zofran products in the U.S. market has carried the same pregnancy warning since 1993:

“Pregnancy: Teratogenic Effects: Pregnancy Category B. 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.”

Physicians continue to prescribe Zofran as an “off label” medication for morning sickness. Currently, an estimated one million pregnant American women are prescribed Zofran each year. Canadian officials are not so lax in terms of warnings about the use of Zofran during pregnancy.

Contrast the Canadian pregnancy warning with the U.S. warning above:

“The safety of ondansetron for use in human pregnancy has not been established,” and “use in pregnancy is not recommended.”

Contact a Dedicated Pharmaceutical Litigation Attorney

If you were prescribed Zofran during your pregnancy and believe you may have grounds for a lawsuit, you need to contact a qualified attorney. For the sake of your child’s future, call the law offices of Farah & Farah at (800) 533-3555 for a free consultation. We are currently investigating Zofran related injuries nationwide.

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