Efficacy of Zofran for Pregnancy Questioned in Recent Study

Published on March 18, 2015 by Sandy Liebhard

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A study published last spring raised questions about the wisdom of using Zofran (ondansetron) to treat pregnancy-related nausea and vomiting, in light of an alternative medication that appears to be just as effective. The concerns raised by the research are important, especially considering the rising number of Zofran lawsuit filings that claim the medication can cause birth defects.

According to the study, which appeared last May in Obstetrics & Gynecology, up to 85% of pregnant woman will experience nausea and vomiting during their term. While its effects have not been well studied in this patient population, Zofran is often prescribed to pregnant women experiencing gastric distress. However, the study found that it was no better at preventing nausea and vomiting in expectant mothers compared to another, less expensive medication called metoclopramide.

In reaching their conclusions, the authors of the report looked at 160 pregnant women with hyperemesis gravidarum, from November 5, 2011, to August 4, 2012, and randomly assigned them to receive either 4 mg of Zofran or 10 mg metoclopramide every 8 hours for 24 hours. The women tracked their nausea and vomiting via a diary, and rated their well-being on a 10-point scale.

“In this randomized trial of these two agents used as intravenous therapy for 24 hours for hyperemesis gravidarum, no differences in efficacy or well-being were noted,” the authors of the study wrote.

“Metoclopramide is effective and economical, has a long history of widespread use, has an excellent fetal safety record, and remains a reasonable first-line short-term antiemetic choice in hyperemesis gravidarum despite the better tolerability of ondansetron,” they concluded.

Is Zofran Safe for Pregnancy?

Since that study was published, at least two Zofran lawsuits have been filed in the U.S. questioning the drug’s safety for a developing fetus. Both of these claims allege that children were born with serious heart birth defects after their mothers were prescribed the drug to treat nausea and vomiting during their first trimester. Among other things, the complaints accuse GlaxoSmithKline of concealing the association between Zofran and birth defects, and of improperly promoting the drug as a treatment for morning sickness, even though it hasn’t been approved for this use.

Given the frequency with which Zofran is prescribed to pregnant woman, it’s likely that many similar lawsuits will be filed in the future. The nationwide law firm of Bernstein Liebhard LLP is actively investigating the link between this drug and birth defects, and our Zofran attorneys are providing free, no-obligation case reviews to potential plaintiffs. If you would like to learn more, please contact our office by calling .

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