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    Zofran Lawsuit Update: Plaintiffs Discover The CDC Tracks Birth Defects

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    Zofran plaintiffs have discovered that the CDC has been tracking birth defects in 41 states.

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    As Zofran litigation continues to move forward with over 200 complaints consolidated under MDL 2657, plaintiffs have been made aware of the Centers for Disease Control and Prevention birth defect tracking system.

    The department has a system in place in 41 states. The purpose of this tracking is to:

    • track if birth defects are decreasing or increasing over time
    • try and identify what may be causing the birth defects
    • bring public awareness to any causes or risk factors found
    • help parents whose children have been born with a defect find assistance

    Plaintiffs are now questioning if this tracking system may show what other studies have reported - that the use of Zofran during pregnancy results in an increased risk of birth defects in an unborn child.

    Each of the complaints filed against GlaxoSmithKline (GSK) alleges that the drug caused a birth defect such as transposition of the greater vessels, atrial septal defect, ventricular septal defect, cleft lip, cleft palate, clubfoot, respiratory distress syndrome, and kidney defects. These defects are severe enough that most of the children required surgical correction and ongoing care.

    The CDC certainly has had enough time to collect data regarding the drug and birth defects. Zofran was approved for use by the U.S. Food and Drug Administration in 1991 for patients experiencing nausea and vomiting after radiation, chemotherapy, and anesthesia. Not long after that, GSK began to advertise the drug as a safe and effective treatment for morning sickness, a condition that is frequently diagnosed in pregnant women during their first trimester. The drug, however, was not approved as a treatment for this condition by the FDA.

    The drug was not approved for this use because the company did not perform human clinical trials to test the safety of the drug for expectant mothers. GSK did, however, perform testing on animals. The results from this testing reported that pregnant rats and rabbits suffered from total litter loss, premature births, ataxia, and weight loss. Their offspring showed developmental retardation including asymmetry of the skeleton and incomplete ossification.

    Each of the plaintiffs is alleging that GSK has been negligent for failing to inform the medical community and public of these findings, for not pursuing human clinical trials, and for not seeking FDA approval before advertising the drug to expectant mothers for off-label use.

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    Michael Monheit



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