In 2014, the Toronto Star had reported a certain anti-morning sickness drug had been allegedly causing birth defects in unborn fetuses. Similarly in America, the medication Zofran (ondansetron) has also been reportedly showing a strong correlation between prescribing mothers and infants born with birth defects.

In Canada, Zofran is approved to treat nausea in chemotherapy patients, but it has yet to be approved to treat morning sickness. However, doctors still reportedly prescribe Zofran for the off-label purpose of treating extreme morning sickness conditions like hypermesis gravidarum.

For these conditions, the expecting mothers suffer almost constant nausea and extreme vomiting. According to the U.S. Food and Drug Administration (FDA), at least 20 pregnant Canadian women who were prescribed Zofran had experienced devastating side effects, including two infant deaths and multiple cases of heart or kidney birth defects.

Four of these infants were reportedly less than four-and-a-half pounds, along with six of them being diagnosed with fetal growth restriction. The Toronto Star had analyzed these Canadian injury reports submitted to the FDA between 2010 and 2013, each of which were submitted by either concerned patients or healthcare providers.

Additionally, there have been several studies centered on Zofran side effects which have conflicting results. For example, one study that was published in the New England Journal of Medicine had stated that Zofran was safe for fetuses, but other studies have contradicted these findings.

This is a major concern for mothers everywhere because they need to know what is safe to ingest during pregnancy. Furthermore, mothers who suffer from extreme morning sickness need to know what other treatment options may be available.

Despite the possible risks this drug presents to unborn children and their mothers, the current Zofran label does not include birth defects. Medical experts warn that the danger for birth defects is the most prominent during the first trimester, the most vital stage of fetal development and where morning sickness is at its worst.

This could potentially lead Zofran maker, GlaxoSmithKline, to face Zofran lawsuits for failing to warn their consumers about these Zofran side effects.

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.

Overview of Zofran Side Effects

Zofran was approved by the FDA in 1991 to treat nausea and vomiting in patients who had recently undergone surgery and going through chemotherapy. This drug works by blocking the receptors that signal nausea and vomiting, which makes it a popular treatment choice for pregnant women.

Ever since its release, it has often been prescribed to pregnant women by doctors when the mother experiences extensive nausea and vomiting.

Medical and legal experts suspect that because of its popularity, that it is still available for pregnant women upon request. However at this point, the FDA highly recommends that doctors do not prescribe the medication due to the high risk of birth defects.

Doctors and medical experts are currently unsure as to why this drug may cause birth defects, but some speculate that it may have to do with the fact that Zofran was only meant to treat nausea in specific nausea cases like chemotherapy and radiation treatment.

In 2013, two significant Zofran studies were published that observed Zofran birth defects but, like previous studies, had conflicting results. The first was a Danish study that observed 600,000 births, which found no increased risk of birth defects from taking Zofran.

Six months later, another study had observed 900,000 births from the same registry as the previous study, but found that there was a 30 percent increased risk of birth defects after taking Zofran.

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.”