Healthcare experts across the country are warning expecting mothers about using the anti-nausea medication Zofran. Normally used to treat nausea in chemotherapy patients, it is currently being investigated for allegedly causing birth defects.

Morning sickness is a very common, but inconvenient hassle, for first-time or experienced mothers that occurs due to the hormone level changes in their bodies. A variety of remedies and treatments are offered for this condition, with Zofran being recently recommended to treat the problem.

However, Zofran has not been approved to treat morning sickness. Specifically, it is often prescribed for the off-label treatment option for women with extreme morning sickness conditions, like hyperemisis gravidarum.

Some of the most important stages of development of the fetus occurs during the first trimester of the pregnancy, which is also when morning sickness occurs most often. This means that Zofran has been prescribed to women at the most important segment of their pregnancy, which makes the likelihood of Zofran causing birth defects to be much higher.

As of now, the FDA has found no studies of Zofran being used during pregnancy but still cautions women against using the drug, and that it should only be prescribed in extreme situations.

However, pregnancy resource centers heavily caution against the drug, stating that using the drug during early pregnancy may cause the infants to be born with cardiac defects, cleft palates and other physical deformities. Additionally, pregnancy experts also warn that Zofran can possibly cause an electrolyte imbalance in pregnant women, due to the constant nausea and vomiting.

In its original 1992 warning label, it did not mention any risks with pregnancy but the recent concern has caused Zofran’s manufacturer, GlaxoSmithKiline, to update Zofran’s warnings to include pregnancy complications on Jan. 14, 2015. Unfortunately, GSK had allegedly begun to market Zofran to pregnant women before this update, which directly contradicts its approved uses set by the FDA.

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.”

Overview of Zofran Birth Defects

Zofran works by reducing the level of serotonin in the patient’s body. Essentially, Zofran disrupts the nausea and vomiting signals sent from the brain to the rest of the body, which numbs the queasy feelings. Due to this quick-acting nausea remedy, it is often requested by pregnant women to treat their morning sickness symptoms, which is not approved by the FDA.

While doctors are allowed to prescribe medications for off-label purposes, it is illegal for pharmaceutical companies to market them for such reasons. GlaxoSmithKline is under fire for this exact reason, as it has been discovered that the company may have directly marketed Zofran to expectant mothers.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Currently, medical experts are unsure as to why Zofran may be causing birth defects in unborn children but suspect that it may be linked to the patient’s hormone levels.