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    Zofran Lawsuit Update: Canadian Drug Label Differs From U.S.

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    The plaintiffs who have filed a Zofran lawsuit have found that the Canadian label for the drug warns pregnant women to not use the drug.

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    With over 200 lawsuits filed against GlaxoSmithKline (GSK), the drug Zofran has been in the news quite a bit lately. The plaintiffs involved have been vocal about their concerns and about the allegations they have made. Recently, they announced that it had been discovered that the label on Zofran in Canada differs from the U.S. label in a very important way - it warns against the use of the drug during pregnancy.

    The Canadian label states, "the safety of ondansetron for use in human pregnancy has not been established," and "the use of ondansetron during pregnancy is not recommended".

    This difference is an important one because each of the lawsuits filed in the U.S. alleges that the drug caused a birth defect in an unborn child. Birth defects listed in the allegations include kidney defects, clubfoot, cleft lip, cleft palate, atrial septal defect, ventricular septal defect, and transposition of the greater vessels. These defects are severe enough that nearly every child has been forced to endure a surgery.

    The parents who have filed these complaints on behalf of their children are also alleging that the company knew the drug had the potential to cause issues when taken by a pregnant mother because they had done animal testing which resulted in defects to the fetuses of pregnant rats and rabbits. They also claim that GSK promoted the drug unlawfully because they advertised it for "off-label" use.

    Zofran was approved by the U.S. Food and Drug Administration in 1991 and has been available to patients through prescription since then. The administration, however, did not approve the drug for use during pregnancy as a treatment for morning sickness.

    These lawsuits have been consolidated in MDL 2657 by the Judicial Panel on Multidistrict Litigation. Both GSK and the plaintiffs were in favor of the consolidation as it will most likely save everyone time and money.

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    Michael Monheit



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