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Zofran Recalls & FDA Warnings

GlaxoSmithKline’s potent anti-nausea drug Zofran is approved to treat the severe nausea and vomiting often experienced by patients receiving chemotherapy and radiotherapy, along with those undergoing surgical anesthesia. But immediately after the drug’s approval, physicians began to use Zofran for an unapproved purpose: treating morning sickness.

Now, multiple large studies have linked “off label” use of Zofran during early pregnancy to an increased risk for major birth defects, including certain orofacial clefts and heart abnormalities.

While this litigation is currently closed, learn more about a Zofran Heart Defects from our team of attorneys.

Litigation Status: Inactive
Accepting Clients: No
Content Author: Laurence Banville
Edited By: Emily Smith
Published: 0707/2929/15151515
Fact checked on: 0707/2929/15151515
"The lawyers that form this alliance truly work on these cases and often take leadership positions on the steering committees that litigate them." - Laurence Banville

Has The FDA Issued A Safety Warning About Zofran & Birth Defects?


The US Food & Drug Administration has not yet released any public announcements in regard to Zofran’s recent association with birth defects.

While the FDA has yet to weigh in on this pressing issue, the agency has released two safety warnings in regard to other risks associated with Zofran.

In one, published on June 29, 2012, the FDA cautioned patients and physicians about Zofran’s link to Torsade de Pointes, an abnormal heart rhythm that can be fatal.

The second warning came on September 18, 2014. In another Safety Communication, the FDA announced that Zofran had been associated with an increased risk for serotonin syndrome, a potentially fatal condition in which the body is literally poisoned by increased levels of serotonin, a neurotransmitter researchers believe is central in causing nausea and vomiting.

Has There Been A Recall?


Zofran is still on the market, along with numerous generic versions of its active ingredient ondansetron.

In the absence of regulatory action, parents across the country are filing legal claims against GlaxoSmithKline. These families claim that exposure to Zofran caused their children to be born with major birth defects. Among their allegations: GlaxoSmithKline promoted its drug for “off label” use during pregnancy, in violation of federal law, while hiding mounting evidence of Zofran’s link to birth defects.

Did GlaxoSmithKline Conceal Safety Data?

This is one of many troubling accusations made in numerous Zofran birth defect lawsuits.

Plaintiffs cite a series of early studies, conducted on pregnant rats and rabbits, that GlaxoSmithKline performed prior to the drug’s approval. One of these studies demonstrated that Zofran’s active ingredient easily crosses the placental barrier, entering embryonic tissue after traveling through a pregnant animal’s bloodstream. Submitting the results to the FDA in support of Zofran’s approval application, GlaxoSmithKline told the agency that none of the animal studies revealed evidence of maternal or fetal harm.

But in their Zofran lawsuits, more than a dozen US families say that was a lie. According to these parents, GlaxoSmithKline’s early animal studies revealed significant signs of toxicity: pregnant animals appeared lethargic and assumed abnormal postures. According to Plaintiffs, the effects of Zofran exposure on offspring were even more pronounced. The offspring showed evidence of severe developmental retardation, including insufficient bone growth and malformations, Plaintiffs write. Many of the newborn animals were born prematurely, Plaintiffs claim in their compliant, while others died in utero.

None of these alleged study results were reported properly to the FDA, Plaintiffs say.

Families also claim that GlaxoSmithKline has been underreporting reports of birth defects with suspected ties to Zofran. They say that the company has concealed many of these reports from the FDA, and has failed to warn the public of Zofran’s potential risks.

Can More Families File Lawsuits?


Any parent who was prescribed Zofran as a morning sickness treatment and then delivered a baby with major birth defects may be eligible to file a claim.

Banville Law has joined a coalition of distinguished attorneys to help parents and birth defect survivors learn more about their legal options. Our experienced lawyers offer a free consultation to any family interested in finding more information about the ongoing Zofran litigation, the drug’s association with birth defects and their own case eligibility.

Our legal services come at no cost, too. Banville Law’s attorneys always work on a contingency-fee basis, so you pay nothing until we secure a favorable court award or settlement in your case.

Continue Reading: Zofran Potential Side Effects: Cleft Palate

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