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GlaxoSmithKline Promoted Zofran Off-Label Use


Zofran (Ondansetron) is not approved by the Food and Drug Administration (FDA) as a treatment for morning sickness, or nausea and vomiting of pregnancy (NVP). According to FDA regulations, doctors may prescribe drugs for off-label use, but drug manufacturers may not promote such uses. Doctors may legally prescribe Zofran “off-label” to pregnant women but the manufacturers of Zofran cannot promote those uses. Off-label use is using drugs for unapproved indications. In this case, Zofran is approved for treatment of nausea and vomiting related to chemotherapy, radiation, and surgery but not nausea and vomiting of pregnancy.

GlaxoSmithKline (GSK) manufactures Zofran. They directly promoted and marketed Zofran for off-label uses (i.e. nausea and vomiting of pregnancy) to doctors. This is illegal. In 2012, the United States government actually sued GlaxoSmithKline for these illegal practices. The lawsuit explicitly stated, “GSK knowingly: (a) promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea); (b) made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”  GSK plead guilty and eventually paid a $3 Billion fine in order to resolve fraud allegations and failure to report safety data. The failure to report safety data refers to the fact that Zofran has never been adequately tested and determined safe for use in pregnant women.




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