Zofran Birth Defects

Zofran (ondansetron) is an anti-nausea drug manufactured by GlaxoSmithKline. It is intended for patients experiencing nausea after chemotherapy or surgery. Many doctors had also prescribed Zofran as a help for women experiencing severe morning sickness during pregnancy. However, the drug was not approved for this type of use. (The term “off-label” prescribing is what is used to describe using a drug for something other than its original intent.)

The U.S. Department of Justice charged GlaxoSmithKline of marketing Zofran to physicians for the treatment of morning sickness even though it was not approved to do so. In 2012 the company pled guilty to “resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs” and paid $3 billion to resolve the case.

Studies have shown the association between the use of Zofran and birth defects. Hundreds of lawsuits have been filed against the maker of Zofran claiming that the company knew of the adverse effects of Zofran on fetal development yet did not do anything to adequately warn the public or medical professionals of this possible outcome. As of 2015 the company had received more than 200 reports of birth defects suspected to be caused by the use of Zofran during pregnancy.

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