You're probably familiar with the phrase "morning sickness." Vomiting, nausea – all unpleasant experiences, but often part and parcel of a woman’s first trimester of pregnancy.
Pharmaceutical company GlaxoSmithKline LLC (GSK) had a potential remedy for morning sickness, but that remedy has been plagued by concerns about birth defects. In 1991, GSK began manufacturing a drug known as “Zofran” (ondansetron) which was approved as safe for use in preventing nausea and vomiting caused by chemotherapy and radiation therapy in cancer patients as well as for surgery. GSK then began marketing the drug to pregnant women without proper scientific testing.
Below, you will find answers to some of the most frequently asked questions about Zofran pregnancy issues and where to go for more information if you or your child experienced any adverse side effects after taking Zofran during the first trimester of your pregnancy.
Q: What is Zofran?
Zofran is an anti-nausea medication that's often prescribed for morning sickness during pregnancy. The drug works by blocking serotonin receptors in the brain, which helps suppress the feeling of nausea.
Q: What pregnancy risks are associated with Zofran?
There are conflicting theories on the safety of Zofran use by pregnant women. According to recent studies, Zofran has been linked to an increased risk of certain heart and birth defects, including cleft palate and club foot in children. Other risks associated with Zofran use include skeletal abnormalities, defects, or disfigurement.
While the Centers for Disease Control (CDC) have issued a warning of possible birth defects related to ondansetron use in pregnant women, the center ultimately concluded more research was necessary. At this point, further research is needed to determine whether ondansetron is safe to use if you are pregnant.
Q: Did GSK perform any studies on Zofran before marketing it to expectant mothers?
GSK did not perform any studies or research on the effects of Zofran on pregnant women or the fetus prior to marketing it for this “off-label” use. In over 200 lawsuits across the U.S., affected patients claim Zofran is a dangerous drug and that GSK failed to warn patients and health experts of its alleged potential to cause birth defects. In 2015, drugmaker Novartis acquired the rights to market Zofran and has also been named a party to several of the lawsuits.
Q: Did the FDA approve Zofran for use in pregnant women?
No, the United States Food & Drug Administration (FDA) has not approved Zofran for use in pregnant women. However, the FDA has approved the drug for the prevention of nausea or vomiting associated with chemotherapy and radiotherapy as well as in some instances following surgery.
Q: Are there currently any lawsuits against GSK?
Yes, there are several lawsuits pending around the country, including a consolidated class action in U.S. District Court of Massachusetts. Specifically, injured parties have filed lawsuits claiming that GSK and Novartis:
Q: What should I do if I think my pregnancy has been affected as a result of using Zofran?
If you believe Zofran has caused a birth defect in your baby, you should first seek appropriate medical treatment. You may also want to consult with an experienced attorney to learn more about your options and the viability of any claim against the drug manufacturer, GSK.
Curious About Legal Claims Related to Zofran Pregnancy Issues? Talk to a Lawyer
If you or your child has been harmed after being prescribed Zofran, you should first contact your doctor or other healthcare professional. It's also in your best interests to contact an experienced drug and medical device attorney to protect your rights. That way, your legal options will be covered and you can focus on your health and the health of your child.
Contact a qualified product liability attorney to make sure your rights are protected.