Doctors prescribe Zofran (ondansetron) to pregnant women as a treatment for nausea and vomiting during pregnancy. Unfortunately, studies link the medication to birth defects, and families are taking drugmaker GlaxoSmithKline to court, saying it marketed the drug to pregnant women without FDA approval.
Unapproved Zofran Use
The U.S. Food and Drug Administration approved Zofran to help cancer patients with nausea after treatments or after surgery. It helped people who vomited as a side effect from chemotherapy or who grew sick after taking post-op meds to help with pain or other complications.
But drugmaker GlaxoSmithKline soon found other patients to take the drug – pregnant women suffering from morning sickness. There was just one problem. The FDA never approved Zofran for use by pregnant women.
In 2012, Glaxo pleaded guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion as part of the legal settlement. Now the company is going back to court to defend more specific allegations about Zofran (ondansetron).
Why Are Former Zofran Users Filing Lawsuits?
Court documents show Glaxo knew as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies because the drug passes through the human placenta. Despite this knowledge, the drugmaker continued to market the drug to pregnant women.
- Lawsuits assert a number of claims against Glaxo. Among them:
- failure to ensure its drug was safe before offering it to the public and failed to determine safety risks before selling it.
- failure to warn the public about dangerous side effects.
- advertising the drug (Zofran) as a safe treatment for morning sickness and nauseua
- misrepresenting results of clinical animal studies and research
- failing to use all data and safety information on Zofran for use in pregnant women.
- producing a defective drug and
- claiming that Zofran was safe for pregnant women.