For the thousands of people every year who undergo chemotherapy or radiation treatment, one of the most unpleasant side effects is nausea. 

Zofran, a drug manufactured by GlaxoSmithKline was approved by the FDA in 1991 specifically for post-surgical-, chemotherapy- and radiation-induced nausea.

However, Zofran would go on to become more popular for an off-label use: combating morning sickness associated with pregnancy. 

Eventually, Zofran would become the top-selling anti-nausea medication in the US for morning sickness. 

Zofran Carries A Risk Of Birth Defects And Serotonin Syndrome For Expectant Moms

Despite the promise of preventing morning sickness, the Food & Drug Administration (FDA), issued a warning in 2013 against ondansetron (Zofran is the brand name) because of an association between use of the drug in early pregnancy and the development of congenital cardiac malformations and oral clefts (cleft lip and palate) in newborns. 

In addition to risks to newborns, Zofran also posed side effect concerns to expectant mothers. Most seriously, the drug was shown to have caused Serotonin Syndrome, which causes serious cognitive and behavioral changes as well as neuromuscular changes; the condition can be fatal. 

For pregnant women looking for a safer drug, Diclegis is now the only FDA-approved prescription for morning sickness. Women can still take Zofran for pregnancy; the drug has not been banned by the FDA. But the drug never received approval specifically for morning sickness. 

According to data provided by MGH Center For Women’s Mental Health, in 2001, less than one percent of pregnant women used Zofran for morning sickness. By 2014, that number rose to over 22 percent, which according to DrugWatch.com, amounted to 110,000 monthly subscriptions that year. 

MGH references a 2019 meta-analysis retrospective study that examined the risk of Zofran in pregnant women. Over 88,000 first-trimester pregnancies were analyzed. 

The conclusion of the study reads, “Although the findings lack consistency, it looks as if ondansetron exposure may be associated with an increased risk of heart defects and/or orofacial defects, and possibly may be associated with other major malformations.”

According to a law firm that handles Zofran litigation, Tor Hoerman, a research study that examined nearly 900,000 pregnancies found statistically significant risks associated with Zofran.

Hundreds of Families Have Filed Zofran Claims

Whether or not Zofran definitively causes birth defects remains up for debate. Nonetheless, according to DrugWatch.com, GlaxoSmithKline (GSK) has been named in more than 600 actions in federal court. 

Plaintiffs allege that GSK unlawfully and fraudulently promoted Zofran as a way to treat morning sickness, despite not being approved by the FDA for such use. The lawsuits also claim that GSK misrepresented the results of research studies to show the drug was safe; in reality those studies, allege the plaintiffs, showed abnormal bone growth and signs of toxicity.

GSK: A Criminal History of Promoting Off-Label Drugs

There’s nothing inherently wrong about doctors prescribing approved pharmaceuticals for off-label use. What is illegal, however, is the marketing of drugs by manufacturers for off-label use. GSK is accused of doing just that. 

According to DrugWatch.com, the first Zofran lawsuit was filed in 2015, by a Minnesota mother whose two daughters were born with congenital heart defects. (One other lawsuit was filed that same year; the lawsuits are still-ongoing.) 

Court documents from that case show that since the early 1990s, GSK knew that Zofran presented “unreasonable risk of harm” to developing babies because the drug passes through the human placenta. 

GSK, however, continued to market the drug to pregnant mothers. Furthermore, the lawsuits claim that GSK paid doctors to prescribe the problematic drug.

But Zofran wasn’t the only drug that GSK was accused of illegally promoting. In 2012, the company paid a $3 billion settlement to the U.S. and certain states, after the company pleaded guilty to paying kickbacks to doctors for prescribing Zofran and eight other drugs, according to Drug Watch. 

Despite the fact that Zofran lawsuits are six years in the making, the litigation remains in its infancy.