The anti-nausea medication Zofran® (ondansetron) received approval from the U.S. Food and Drug Administration (FDA) in 1991 to treat patients who had recently undergone chemotherapy or other serious surgeries.
However, doctors routinely prescribed Zofran to treat morning sickness in pregnant women during their first trimester. This was not a use approved by the FDA, and a recent study sheds light on the possibility that taking Zofran during pregnancy may impact the health of a mother’s fetus.
A study published by the Center for Birth Defects Research and Prevention in 2012 examined nausea and vomiting of pregnancy (NVP) in over 10,000 women. It examined the frequency of NVP in pregnant women and measured the rate of birth defects in women who suffered from NVP. What the study concluded is that there is no definite link between NVP or morning sickness and birth defects, but there may be a link between the drugs which treat morning sickness and birth defects.
The preliminary findings from this study were presented at the Center for Birth Defects Research and Prevention’s annual meeting in San Antonio, Texas as early as 2004.
Drugs like Zofran are not FDA approved for use to treat morning sickness, and yet they are very commonly given to women for that very reason. During pregnancy, women have an increased incentive to obey doctors’ orders and keep their unborn child safe by utilizing the recommendations of their physicians. Many women who took Zofran during pregnancy may have unknowingly exposed their fetus to the risk of birth defects, like cleft lip or palate, kidney malformations, limb deformities and congenital heart defects.
The manufacturer of Zofran, GlaxoSmithKline (GSK), has already settled a lawsuit brought by the federal government over the illegal marketing of the drug. GSK was providing financial incentives in the form of kickbacks to doctors who prescribed Zofran for morning sickness, against the FDA’s wishes. Lawsuits are now being filed by women who have been harmed by the dangerous side effects of Zofran.
If you or someone you love had a child born with a birth defect after taking Zofran for morning sickness, you have legal rights that we are ready to protect. Contact The Eichholz Law Firm today to discuss your legal options.
1. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects, Marlene Anderka, Allen A. Mitchell, Carol Louik, Martha M. Werler, Sonia Hernández-Diaz, Sonja A. Rasmussen and the National Birth Defects Prevention Study,http://onlinelibrary.wiley.com/doi/10.1002/bdra.22865/abstract;jsessionid=B099FB56B06D49885ADCEA1122BF6B6A.f03t04, Feb. 23, 2015