The anti-nausea medication Zofran (ondansetron) has been regularly prescribed off-label to pregnant women to treat morning sickness. However, according to recent reports and Zofran studies, this anti-nausea drug has been connected with an increased risk of birth defects.

As a result, many mothers are now filing Zofran birth defects lawsuits against the drug’s manufacturer GlaxoSmithKiline.

History of Zofran

Zofran was first approved by the FDA in 1991 to treat vomiting and nausea that many patients experience due to undergoing chemotherapy and surgery. Over time, doctor’s became aware of Zofran’s ability to alleviate morning sickness symptoms (including a severe form of morning sickness known as hyperemesis gravidarum) if women took Zofran while pregnant.

Using Zofran for morning sickness treatment is not an approved FDA use for this anti-nausea drug. While it is not illegal for a doctor to prescribe a drug treatment for off-label (or unapproved) uses if the treatment is deemed necessary, it is illegal for a pharmaceutical company to promote pharmaceutical drug products to doctors and patients for off-label procedures.

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.

Background on Zofran Birth Defects

According to reports, Zofran has been categorized by the FDA as a “Pregnancy Category B” drug, which indicates that while there are no controlled human studies on the subject at the time the drug was approved in 1990s, animal testing of Zofran has shown that the anti-nausea drug presents a risk to an unborn child still in the womb.

However, newer Zofran studies have been conducted that have involved the review of hundreds of thousands of births, and support the theory linking Zofran use during pregnancy to the development of birth defects.

One Danish study in particular, published in 2013, reviewed 900,000 birth from a Danish birth registry and allegedly found that the use of Zofran during pregnancy increased the risk of birth defects by 30 percent, as well as doubling the risk of heart defects in unborn children.

Another Zofran birth defects study was conducted in 2012 by the Center for National Birth Defects Research and Prevention. This study found that using Zofran during pregnancy (especially the first trimester) could lead to a 2.4 increased risk of giving birth to a child with cleft lip or cleft palate.

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.”

The drug labels for Zofran do not include a warning to expectant mothers of the potential risks associated with a Zofran pregnancy and do not mention the possible birth defects linked to the use of the drug as a morning sickness treatment.

You should talk to a birth defects lawyer if you believe your child was born with Zofran birth defects to see if qualify to file a Zofran lawsuit.