Over 200 Zofran lawsuits have now been filed across the country. Zofran is a medication approved by the FDA to treat nausea in chemotherapy patients and people undergoing surgeries. It has also been prescribed “off-label” by doctors for years to treat extreme morning sickness in expectant mothers. “Off-label” refers to a doctor’s ability to prescribe a medication to a patient even if it is not approved by the FDA for that use. However, the makers of Zofran, GlaxoSmithKline, illegally promoted their drug as a safe treatment for morning sickness and in some cases may have offered kickbacks to doctors for prescribing the drug. Now, Canada’s label for Zofran includes warnings for pregnant women. The United States, however, does not.
The Canadian Warning
Canada’s warning label for Zofran’s generic form, ondansetron, reads: “the safety of ondansetron for use in human pregnancy has not been established,” and “use in pregnancy is not recommended.”
The parents of babies born with birth defects are now wondering why America’s Zofran warning label does not include a similar warning.
The U.S. Warning
How does the U.S.’s Zofran warning label differ from Canada’s? Well, instead of explicitly stating that Zofran could be dangerous, it tries to use a roundabout way of saying it. The only warnings found in Zofran’s label regarding its safety during pregnancy is this:
“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.”
There are no mentions of potential birth defect risks, and unlike Canada’s warning, does not include the phrase “not recommended” for pregnant women.
Contact a Zofran Attorney
If your baby was born with Zofran birth defects and you think you might have a claim, our lawyers at Jones Ward, PLC are here to help. We know it may seem like a daunting and overwhelming process, but we will do everything we can to make it as easy as possible. Take the first step and fill out ouronline form to receive feedback from a trusted attorney. We will guide you step by step through the process and answer any questions you may have. You can also call us at 888-595-2922.
