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Anti-Nausea Medication, Zofran, Linked to Serious Birth Defects

Zofran is a prescription medication used to prevent nausea and vomiting. The FDA has approved it for use in patients who are recovering from surgery or who are undergoing chemotherapy or radiotherapy. Although not approved to treat morning sickness, it is prescribed off-label to pregnant women. In fact, it is estimated that approximately one million pregnant women take Zofran or its generic equivalent each year.

Unfortunately, over the past few years, several studies have linked Zofran with birth defects, particularly when ingested during the first trimester of pregnancy. A 2012 study concluded that taking Zofran during the first trimester doubled the risk of cleft palate birth defects. Another study, released in 2013, concluded that taking Zofran during the first trimester doubled the risk of cardiac malformations, leading to a thirty percent increased risk of major congenital malformations.

Recently, GlaxoSmithKline, the manufacturer of Zofran, asked the U.S. Judicial Panel on Multidistrict Litigation to transfer all cases filed in federal court to the U.S. District Court for the Eastern District of Pennsylvania. In its Motion for Transfer, GSK said that it anticipates more Zofran filings in the coming months and requested that all current and future federal claims be transferred to the Eastern District of Pennsylvania. GSK argued that the creation of the MDL in the Eastern District of Pennsylvania “will [also] help facilitate the efficient disposition of parallel state court actions,” including those already filed in the Philadelphia Court of Common Pleas. Stay tuned for updates on this emerging litigation.