Zofran and Its Side Effects

Although it is only used for off-label use in pregnant women, Zofran can cause side effects that affect both the mother and the child. In fact, there are many birth defects that have been linked to ondansetron use, many of them highly debilitating and permanent. What’s infuriating is that ondansetron is placed in the FDA’s pregnancy category B, which suggests it is safe to use in pregnant women. And these women are often not informed that the drug was never approved for use in expecting mothers, essentially making them into unwilling test subjects.

Ondansetron was approved by the FDA in 1991, and acts on a set of receptors that signal the release of serotonin in the blood, effectively reducing the concentration of the neurotransmitter. This can suppress nausea and vomiting, though ondansetron was only intended to be used in patients recovering from chemotherapy, radiotherapy or surgery. However, the drug’s manufacturer, GlaxoSmithKline, found that it could produce another market for its medication by appealing to women suffering from morning sickness. Nausea and vomiting during pregnancy can be extremely stressful, forcing women to seek relief right away. Unfortunately, many of these women were treated by doctors who ignored the lack of research regarding ondansetron, and responded to GlaxoSmithKline’s aggressive marketing to medical professionals. As a result, doctors regularly prescribed ondansetron for off-label use in pregnant women for years.

But even as far back as the 80s, there was trepidation regarding ondansetron’s use in expecting mothers. The earliest research was performed by GlaxoSmithKline itself, which studied its use in animal subjects. What its researchers found was that exposure to the drug could result in premature births, fetal deaths inside the uterus, congenital heart defects, and retarded development. Unsurprisingly, this research was never made public until court documents revealed it. This was just the beginning, though, as a study performed by the Slone Epidemiology Center in Boston discovered that ondansetron use doubled the risk of cleft palate defects. A 2014 study published in the American Journal of Obstetrics and Gynecology demonstrated that ondansetron use could double the chances of cardiac malformations, and an overall 30 percent increase in major birth defects.

These Zofran related side effects have put the company under fire, and have led to many civil suits against the manufacturer. These claims accuse the company of misrepresenting the risks associated with their medication, unlawfully marketing the product to doctors, and suppressing safety information that could lead to more informed medical decisions. With the staggering amount of evidence against the company, GlaxoSmithKline has been forced to pay at least $3 billion for its gross, criminal negligence. About $2 billion will be directed to patients who have been harmed by the company. This represents one of the largest fraud settlements in the history of the U.S., which should communicate just how severe the company’s recklessness was.

Families who have been harmed by ondansetron are encouraged to speak to a legal professional to weigh their legal options in light of this unprecedented settlement decision.