Zofran® History

Zofran® Resource Center

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Zofran (ondansetron) is an FDA-approved medication for the treatment of nausea and vomiting associated with chemotherapy, radiation therapy, or surgery for cancer patients. It was developed in the mid-1980s by GlaxoSmithKline (GSK) in London. It received U.S. patent protection in 1987 and a use patent in 1998. The FDA approved the drug in January of 1991 to treat nausea and vomiting in cancer patients. The first generic versions of Zofran were approved by the FDA in late 2006.

In 2005 Zofran was the 20th highest-selling brand name drug in the United States. OB/GYN doctors were the most frequent prescribers of Zofran in 2005. According to the FDA, they accounted for approximately 23% of dispensed prescriptions. Oncology doctors only accounted for about 9% of the prescriptions in that same year.

In 2012, GSK pled guilty to the unlawful promotion of certain prescription medications, including Zofran, among other illegal activities. These include failure to report certain safety information and false price reporting. The Department of Justice required the company to pay $3 billion in both criminal and civil damages. GSK paid over $1 billion alone in regards to the off-labeled promotion and kickbacks of Zofran and other medications. The off-label civil settlement also resolved four pending lawsuits in the federal court.

Multiple studies have been conducted on small samples of pregnant women who took Zofran when pregnant. There are contradicting studies as this time with certain studies indicating there are no greater risks associated with taking the drug; however, other studies have indicated higher risks of heart defects and cleft palates.