Zofran Lawsuit Plaintiffs Make Note Of Canadian Label Differences On Drug Which Warn Of Use During Pregnancy

ZofranLegal.com reports on details regarding the warning labels which are used on anti-nausea drug Zofran in Canada versus that of those which come with the U.S. version of the drug. In Canada, the drug’s label indicates potential dangers for use in pregnant women and warns against this consumer group taking the drug. It has been reported that in Canada, the drug’s label states, “...the safety of ondansetron (Zofran) for use in human pregnancy has not been established,” and also, “use in pregnancy is not recommended.” This difference from the U.S. labeling has spurred both concern and questions from plaintiffs currently involved in lawsuits referencing the drug, who wonder why American labels would be missing this critically important information.

Zofran lawsuit plaintiffs across the United States commonly allege that fetal exposure to the drug through the mother places unborn children at increased risk for the development of severe and sometimes fatal birth defects. Lawsuits which have been filed with these claims now number near 250. The suits are filed by parents against corporate giant GlaxoSmithKline, who manufactures Zofran. Defects most commonly linked to the drug in lawsuit allegations are: cleft lip and palate, kidney defects, atrial septal defect and ventricular septal defect, respiratory distress, clubfoot, and transposition of the greater vessels.

Zofran drug use by expectant mothers is a great point of contention among the lawsuit plaintiffs, who indicate that the drug was never FDA-approved to treat pregnant women or tested for safety on them or their unborn children. Despite this fact, however, manufacturer GSK reportedly went on to market the drug widely in an “off-label” fashion, indicating that it was a safe and effective treatment for morning sickness. This marketing led to the issuance of many “off-label” prescriptions to women who were likely unaware that they were taking a drug for an unapproved use by the FDA. After many of these women went on to give birth to babies with defects, Zofran birth defect related lawsuits began to pile up. The lawsuits continue to increase in number today.

While those involved anxiously await their day in trial, the attorneys of Monheit Law are working to assist other mothers who have taken Zofran while pregnant, and who have gone on to give birth to children with defects. Affected women and children may be entitled to significant compensation, and deserve to be given the opportunity to fully explore their rights in the matter. Those affected who wish to further explore their legal options are currently offered free legal consultations by Monheit Law.

To request additional information, or to ask questions regarding Zofran birth defect lawsuits, please contact the attorneys of Monheit Law by calling (877) 620-8411.