{"id":353404,"date":"2016-07-15T18:08:28","date_gmt":"2016-07-15T23:08:28","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/zofran-pregnancy-issues-faqs.html"},"modified":"2023-11-15T10:41:15","modified_gmt":"2023-11-15T15:41:15","slug":"zofran-pregnancy-issues-faqs","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/zofran-pregnancy-issues-faqs.html","title":{"rendered":"Zofran Pregnancy Issues and Lawsuits"},"content":{"rendered":"\n
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Zofran Pregnancy Issues and Lawsuits<\/h1>\n\n
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\n By Christie Nicholson, J.D.<\/a> | Legally reviewed by Oni Harton, J.D.<\/a>\n | Last updated\n
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This article has been written and reviewed for legal accuracy, clarity, and style by FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with our editorial standards<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n\n

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The last updated date refers to the last time this article was reviewed by FindLaw or one of our contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please contact an attorney in your area<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n<\/section>\n\n\n

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Zofran, originally approved to treat nausea in cancer patients, was later marketed off-label to pregnant women without FDA approval. Some women who took Zofran during pregnancy reported birth defects in their children, leading to hundreds of lawsuits against the manufacturer, GlaxoSmithKline.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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An expectant mother wants nothing more than for her child to have a healthy start to life. They may enter pregnancy expecting at least a little morning sickness, but\u00a0would never take an anti-nausea drug if they knew it could harm their baby.<\/p>\n

GlaxoSmithKline LLC (GSK) first asked the U.S. Food and Drug Administration (FDA) to approve Zofran to treat nausea in cancer patients<\/a>. Years later, GSK marketed the drug to pregnant women but didn’t get FDA approval. They promised women that Zofran would help reduce morning sickness in the first trimester.<\/p>\n

Some women who took Zofran gave birth to babies with birth defects. Hundreds of women hired lawyers to file Zofran lawsuits. The plaintiffs argued that the drug manufacturer didn’t warn providers about the risks<\/a>. These birth injuries included cleft palate and heart abnormalities.<\/p>\n

This article explains the use, risks, and side effects of Zofran. You’ll also find an update on the status of the Zofran lawsuit, which ended in January 2023, when the United States Court of Appeals for the First Circuit affirmed the MDL judge’s ruling dismissing all Zofran lawsuits.<\/p>\n

Drug manufacturers have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you or your baby has been harmed by Zofran or another medication, you have legal options. Contact a product liability attorney<\/a> near you to share your story and learn if you have a valid claim.<\/p>\n

Zofran and Morning Sickness: The Basics<\/h2>\n

Zofran is the brand name for the drug\u00a0ondansetron<\/a>. Zofran works by blocking the effects of serotonin, which is associated with nausea and vomiting.<\/p>\n

More than 80% of all women suffer morning sickness, nausea, or vomiting at some point early in their pregnancy. GSK decided to market Zofran for the off-label use of alleviating morning sickness.<\/p>\n

What they didn’t do was warn the public<\/a> about the potential side effects of taking the drug while pregnant. Some mothers claimed that\u00a0their use of Zofran during the first trimester of pregnancy resulted in birth defects.<\/p>\n

Some\u00a0studies have shown<\/a> an increased risk of congenital health issues in babies born to women who used Zofran as an anti-nausea drug during their first trimester. For example, there is evidence that shows the use of Zofran (ondansetron) by expectant mothers increases the risk of:<\/p>\n