Zofran Research Spans 10 Years, But No Still No Warning Label Change from Glaxo

Published on March 20, 2015 by Sandy Liebhard

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The effects of a medication suggested in a number of Zofran lawsuits to cause serious birth defects have been researched for nearly 10 years, yet it continues to be prescribed to pregnant women.

The first was published in 2006 and found that the medication can cross a woman’s placenta, meaning that the newborn may be affected by it in some way, according to the U.S. National Library of Medicine National Institutes of Health. The study did not find a risk for cleft lip and palates, as well as defects related to the heart, kidneys and/or brain, but did conclude that the “developmental significance of this drug exposure requires further investigation.”

zofran warningFive years later, research published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology revealed that women who took Zofran during pregnancy may be 2.37 times more likely to have a child with a cleft palate, which could translate to a severe facial deformity requiring numerous surgeries to correct and the effects may be long-lasting even then.

2014 Study Finds Increased Risk for Zofran Heart Defects

And then there’s the potential for Zofran heart defects. In October 2014, a study published in Reproductive Toxicology determined an increased risk for certain cardiovascular problems in Zofran babies whose mothers used it during their first pregnancy trimester.

Why Hasn’t GlaxoSmithKline Updated Zofran Warning Label?
Despite these findings, which have been obtained by multiple sources, the drug’s manufacturer, GlaxoSmithKline has not conducted a comprehensive study that properly assesses the risk for birth defects. They also haven’t updated Zofran’s warning label to inform the public about research that has analyzed these risks.

It is noteworthy to add that this medication has not been cleared for pregnant women; it is only approved by the U.S. Food and Drug Administration (FDA) to treat chemotherapy, radiation and surgery patients.

Since more and more researchers have explored Zofran problems, a number of women have filed lawsuits that accuse GlaxoSmithKline of failing to adequately warn women about problems that may occur if used during pregnancy. These lawsuits are now pending in various jurisdictions throughout the U.S.

Take Legal Action Against the Makers of Zofran. Call our Firm.

To file a Zofran Lawsuit, contact our Zofran lawyers at Bernstein Liebhard LLP to pursue legal action against the manufacturer of this anti-nausea drug. Call us now at .

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