Every year in America, millions of women become pregnant and experience the excitement and adjustment of impending motherhood. One of the most common adjustments pregnant women contend with is morning sickness, causing many request Zofran from their physicians.

Zofran (Ondanestron) is a popular antinausea medication that is typically prescribed to chemotherapy or surgery patients, and regularly prescribed off-label to battle morning sickness. Morning sickness is severely common in women who are going through the first trimester of pregnancy, as the hormone fluxes have unfortunate side effects on the body. However, many women who had previously taken Zofran have reported babies born with birth defects.

Despite the fact that morning sickness is not among the approved uses, Zofran is commonly prescribed to pregnant women to bring down their nausea levels. While it is not illegal for doctors to prescribe medications for off-label purposes, it is illegal for manufacturing companies to advertise them for such uses. This is what Zofran manufacturer, GlaxoSmithKline, had allegedly done and is now facing major backlash for the allegedly fraudulent actions. For years, the company had advertised Zofran to be a safe and effective morning sickness treatment option, despite not knowing the Zofran side effects the drug could have on unborn babies.

A recent study conducted in 2014 titled “Use of Ondanesetron During Pregnancy and Congenital Malformations in the Infant” illustrates the devastation Zofran could inflict onto developing fetuses. In this birth defects study, data was gathered from the Swedish Medical Birth Register, analyzing the births on 1,349 infants that were born from 1998 to 2012 whose mothers were prescribed Zofran. The results indicated that Zofran could significantly increase the chances of birth defects like cleft palate and cardiovascular defects.

Other Zofran birth defects studies conducted have found similar results, triggering concern from patient within the international medical communities. As stated before, GlaxoSmithKline had been found in violation of federal marketing laws by allegedly misleading pregnant women into believing that Zofran was safe to ingest for their morning sickness. As a result, GlaxoSmithKline has been at the center of numerous product liability lawsuits, and has paid $1.2 billion to settle the charges brought against them by the U.S. Justice Department.

Experts state that pregnant women should always use caution when ingesting prescription medications like Zofran, and should educate themselves as much as possible. If at any point they are unsure about a medication, they should consult their physician. This is especially true when these drugs are taken during the first trimester.

Overview of Zofran Birth Injury Complications

Despite the recent concern of Zofran birth defects, the drug has been on the market since 1991 and was regularly prescribed to treat morning sickness from the very beginning. It is important to note that Zofran had never been approved to treat morning sickness, but an increasing amount of women suffering from extreme morning sickness became desperate for options, resulting in numerous off-label Zofran prescriptions. Instead of adding sufficient warning to Zofran’s label, GlaxoSmithKline had capitalized on this target market, specifically advertising to pregnant women. However, the number of birth defects incidents in correlation of Zofran use has started a Zofran birth defects litigation movement and spurred massive concern among doctors and drug agencies.

In fact, the FDA had issued an official warning of Zofran birth defects in 2011. It stated that Zofran increased the chances of infants being born with certain heart defects like abnormal heart rhythm and septal defects. Despite the warnings, Zofran remains popular among pregnant women with many of them oblivious to risks of the drug. According to a more recent report from the FDA, the agency has received 39 injury reports of Zofran birth defects.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”