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Most Popular Morning Sickness Drug Zofran Presents Risks of Birth Defects

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Zofran (ondansetron) is an antinausea drug originally developed to help cancer patients with the nausea and vomiting associated with chemotherapy and radiation treatments. The drug works by preventing a certain type of nerve receptor from sending signals that the brain interprets as nausea. As doctors started noticing how effective it was, they began to prescribe it to pregnant patients for morning sickness "off-label," which means that the Food and Drug Administration never approved it for that use. It became the most commonly prescribed morning-sickness treatment in America, but now hundreds of mothers are filing lawsuits against Zofran's manufacturers, claiming that it caused severe birth defects, including heart defects, cleft palates and lips, kidney malformations, skull deformities, and club foot.

As of June 2018, 465 lawsuits have been filed against Zofran's manufacturer GlaxoSmithKline (and later Novartis, which acquired the rights to Zofran from GSK). The lawsuits allege, among other things, that GSK knew Zofran was linked to birth defects as early as 1992, yet still promoted the drug to doctors and patients as a treatment for morning sickness. Additionally, GSK is accused of misrepresenting studies about Zofran's safety and failing to warn patients and doctors about its side effects.

While the FDA has avoided commenting directly on the question of safety, the FDA staff did publish a 2017 article examining the prevalence of Zofran use in pregnant women. Their research showed Zofran went from being prescribed in fewer than 1% of pregnancies in 2001 to 22.2% in 2014, while the use of other commonly prescribed antinausea drugs promethazine and metoclopramide increased only modestly from 2001 to 2006, then decreased between 2006 and 2014. The article concludes, "[g]iven the widespread use of [Zofran] in pregnancy, data establishing product efficacy and methodologically rigorous evaluation of post marketing safety are needed."

If you or someone you know has been harmed by taking a medication, contact an attorney at Abraham, Watkins, Nichols, Sorrels, Agosto, Aziz & Stogner by calling 713-396-3964 or 1-800-594-4884.

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