The drug Zofran was created to relieve nausea caused by cancer treatments such as chemotherapy and radiation. However, the maker of the drug, GlaxoSmithKline (GSK), marketed it as a treatment for morning sickness without FDA approval, and doctors prescribed Zofran “off-label” to pregnant women. In 2013, the Food and Drug Administration (FDA) issued a warning for the drug, identifying potential safety issues. Ultimately, hundreds of lawsuits have been filed by those who allege that Zofran caused severe birth defects in their newborns.
How Zofran Harms Babies
Each year, Zofran, or its generic version ondansetron, has been prescribed to approximately one million pregnant women in the U.S. to help alleviate morning sickness. Many of those women filed lawsuits against GSK alleging that the manufacturer did not have “clinical knowledge that the medication was safe to use during pregnancy,” and that GSK intentionally marketed the drug to pregnant women as a safe method for treating nausea during pregnancy. Additionally, it’s alleged that Zofran has been linked to severe birth defects in babies, and GSK failed to communicate these serious side effects to prescribing physicians.
When doctors began prescribing Zofran for an off-label treatment, they unknowingly put unborn babies in danger. Common defects and adverse events linked to Zofran include:
- Heart abnormalities
- Kidney malformation
- Bone malformation
- Cleft palate
- Club foot
Although Zofran poses serious risks to the baby, this drug can cause side effects in the pregnant mother also, including shortness of breath, fainting, difficulties breathing and swallowing, and irregular heartbeat.
You Are Not Alone
If you took Zofran while pregnant, and your child suffered severe birth defects or died, get in touch with the experienced medical malpractice attorneys at the Holton Law Firm. We can discuss your case to determine if you’re eligible for compensation due to the alleged problems with the drug Zofran. Start a live online chat on our website today.