In 2012, GlaxoSmithKline (GSK), the pharmaceutical company that manufactures Zofran, agreed to pay $3 billion to settle claims with the U.S. Department of Justice for a variety of civil and criminal allegations. As part of the settlement, GSK agreed to resolve its civil liability for promoting several drugs, including Zofran, for off-label use. Even though GSK paid settlements of $3 Billion, this has not released the company from liability for damages or injuries that may have occurred as a result of Zofran use.
Zofran is the brand name for the generic medication, odansetron hydrochloride, manufactured by the UK pharmaceutical giant, GlaxoSmithKline (GSK), who has operations in 115 countries and estimated annual revenue of $35 Billion. Available as an oral tablet, oral solution, oral disintegrating tablet and as an intravenous injectable, Zofran was FDA approved to treat or prevent nausea and vomiting in patients receiving cancer treatment (chemotherapy and/or radiation therapy) and in surgery or for post-operative related nausea care.
A 5-HT3 receptor antagonist, Zofran works by blocking serotonin levels in the brain that would otherwise activate a nauseous or vomitous response in patients. An effective anti-nausea medication when used as directed, Zofran began to be used in what is called “off-label” treatment for morning sickness. While physicians are allowed to and often do use certain medications for “off-label” treatments at their professional discretion, usually when they feel the benefits outweigh the risks to their patients (and in this case, the developing fetus of their patient), drug manufacturers are forbidden by law to promote or market medications for these types of uses.
According to the American Journal of Obstetrics & Gynecology (AJOG), “about 1 million pregnant American women are exposed to ondansetron (Zofran) out of 4 million pregnancies a year.” Some recent reports show that using Zofran increases the risk of having a child with birth defects by as much as 30%. A significant percentage considering such a large number of pregnancies exposed each year.
In fact, a 2011 study found that ondansetron (Zofran) can actually double the chance of a child being born with cleft palate.