Pharmaceutical manufacturer GlaxoSmithKline has recently faced numerous lawsuits alleging that taking Zofran while pregnant increases the risk of birth defects in children two-fold.

Zofran, generically known as ondansetron, is an anti-nausea medication approved by the U.S. Food and Drug Administration (FDA) in 1991 to treat nausea and vomiting in cancer patients or post-surgery patients.

The FDA has labeled Zofran a category B drug for women who are pregnant. This means that tests performed on animals demonstrated no risk to animal fetuses at the time the drug was approved. Well-controlled studies reportedly showing the effects on human pregnancy were inadequate at the time of approval.

Regardless of this, many doctors choose to prescribe Zofran for off-label (non-FDA approved) uses, such as pregnancy induced nausea and vomiting.

A 2013 Danish study, which looked at the health records of over 900,000 births, found that taking Zofran during the first trimester increased a woman’s risk of having a child born with cardiac malformations by 30 percent.

Some medical researchers argue that past studies on Zofran have had contradictory findings, and advocate that Zofran has no negative effect on a developing fetus. But new research suggests that past sample studies used sample sizes that were either too small to record accurate findings, or included women who began taking Zofran at 10 weeks, which is past the window of time when malformations would develop.

The International Society of Pharmacoepidemiology also published a study based on data collected over 13 years. Results from the study found that 58 out of 1,248 women who took ondansetron during their first trimester had children born with birth defects.

Medical researchers note that with the multitude of FDA approved drugs that currently exist to treat nausea and vomiting during pregnancy, no reason exists for pregnant women to be exposed to medication unapproved for maternal and fetal safety. Medications approved by the FDA to treat nausea and vomiting during pregnancy include metoclopramide, doxylamine, and pyridoxine.

Taking Zofran while pregnant also creates potential health risks for the mother. Zofran risks include serotonin syndrome which is a severe drug reaction that can cause mental changes and physical symptoms including rapid heart rate, high blood pressure, diarrhea, and loss of muscle coordination.

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 Lawsuits

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.

Zofran lawsuits against the GlaxoSmithKline have been filed in both state and federal court. Plaintiffs generally allege that the pharmaceutical company violated consumer protection laws by failing to warn the medical community and the general public about risks associated with taking Zofran.

The Zofran birth defects lawsuits filed against GlaxoSmithKline include claims for negligence, fraud and deceit, breach of warranty, strict products liability, and misrepresentation. Many plaintiffs hope to recover compensation to help pay past and future medical bills as well as compensate for the pain and suffering they were allegedly forced to endure due to the undisclosed risks.