Zofran, a potent anti-nausea medication that was often prescribed off-label for women during pregnancy, has been linked to an increased risk of causing birth defects. While many medications like Zofran lack conclusive data on their effects on unborn humans, Zofran was studied in pregnant rats and rabbits. Results revealed that the drug’s active ingredient, ondansetron, could cross the placental barrier in mammals.
These studies were conducted in the 1980s, prior to Zofran’s FDA approval. It’s important to note that animal studies are never assumed to predict the outcome for human patients, but physiology is very similar across a variety of mammals. The study results may not prove that Zofran directly causes harm to a human fetus, but it does show that Zofran’s ingredients can travel in a pregnant female’s blood and enter her unborn child.
In 1991, GlaxoSmithKline, the pharmaceutical manufacturer of Zofran, submitted the study results to the U.S. Food and Drug Administration (FDA) during its initial application for approval. Reports showed that the company reported no harm to the fetus in the animal study, but there were signs of “toxicity, premature births, intrauterine fetal deaths, and incomplete bone growth.”
Again, animal studies do not necessarily predict similar outcomes with human studies. However, these study results were allegedly concealed by GlaxoSmithKline from regulatory authorities.
Very little is known about the safety of Zofran’s use during pregnancy. What studies have been done suggest that taking Zofran, especially during the first trimester, increases the risk of birth effects. Unfortunately, morning sickness is often worse during the first trimester, and women are more likely to be prescribed the drug during this critique time of development.
While Zofran has been prescribed for the off-label use to treat morning sickness, the drug’s label does not list the increased risk of causing birth defects. This has led to Zofran lawsuits alleging that the drug manufacturer illegally marketed Zofran and negligently failed to warn consumers and health professionals about the actual risks of taking Zofran during pregnancy.
If you, or someone you love, took Zofran, while pregnant and your baby was born with birth defects, you may have legal rights. Contact the Zofran lawyers at Simmons Hanly Conroy today.