You may be familiar with Zofran, an anti-nausea medication that is often prescribed off-label for women during pregnancy. Zofran has been linked to causing birth defects such as cleft lip, cleft palate, heart defects and more. When pharmaceutical companies rush their products to market without thorough research, everyday consumers like you and me are the ones who are harmed. However, this information tends to sink in more after we’ve seen and heard the stories of the real faces of Zofran birth defects –children like Arianah.
Valley News Live, a news station in North Dakota, recently featured the story of Arianah, a little girl with a heart defect. The two-year-old is facing major heart surgery that could have easily been prevented.
When Arianah’s mother Kylee Riesen was pregnant with her, Riesen suffered from severe morning sickness. Doctors prescribed Zofran, which, at the time, was only approved by the U.S. Food and Drug Administration (FDA) for use in chemotherapy patients to ease nausea. Throughout her pregnancy, Riesen continued to take the drug not knowing its risk of causing birth defects.
Two years later, Arianah is now preparing for open heart surgery to repair her heart defect. The family will have to travel out of town for the surgery, and they will have to stay there for about a month.
Zofran and Birth Defects
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. Many pregnant women like Kylee Riesen took Zofran inferring that the drug was safe during pregnancy – only to have a child born with some type of birth defect requiring major surgery.
Zofran has never been approved to treat morning sickness in women. In addition, 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.
“The FDA doesn’t do studies on pregnant women usually for obvious reasons because you’d put pregnant mothers and their children at risk,” said local pharmacist David Olig in the Valley News Live article.
Arianah is one of many children who are facing difficult surgeries and long roads of recovery that could have been prevented had the risks of Zofran been communicated to pregnant women. Zofran lawsuits allege 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 know took Zofran and had a child with a birth defect, contact the Zofran lawyers at Simmons Hanly Conroy today. We are here to help.