Zofran is a drug prescribed to treat nausea and vomiting caused by chemotherapy in cancer patients. The FDA had approved the drug for managing nausea in cancer patients. However, doctors have been prescribing Zofran “off-label” to expecting mothers experiencing morning sickness. Allegedly, the manufacturer GlaxoSmithKline (GSK) marketed it to doctors as an anti-nausea drug for pregnant women and also made false claims that Zofran is an acceptable and safe drug to treat morning sickness in pregnant women.
Approximately 1 million pregnant women are prescribed Zofran each year in the US. Between 1991 and 2015, the FDA has received more than 400 birth defect related reports linked to Zofran. Many studies have confirmed a link between Zofran and birth defects such as heart defects and cleft palate in newborns. In August 2013, Danish researchers revealed a study, conducted on over 900,000 over a long period of time (1997 to 2010) that showed that 4.7% of the mothers who had taken ondansetron (Zofran’s active ingredient) during their first trimester had babies with congenital malformations. Another study by the Center for Birth Defects Research and Prevention found a two fold increased risk of cleft palate in a newborn baby associated with odansetron exposure in mothers. Birth defects observed in babies linked to Zofran are:
- Cleft Lip
- Cleft Palate
- Heart murmurs
- Kidney Failure
- Webbed toes
- Facial deformities related to the ears, nose and mouth
Besides the increasing risk of birth defects in newborns, FDA has identified a potential safety issue linked to an increased risk for serotonin syndrome in patients taking Zofran. Sertonin syndrome is associated with symptoms like agitation, confusion and drastic behavioral changes in patients. Although studies have pointed in the direction of a possible link rather than a causal one, Zofran’s suitability for pregnant women still remains questionable.
In Oklahoma, about 1900 babies, out of the 53000 born each year, have some kind of birth defect or serious health condition. Managing such health conditions can be a mental and financial strain on families. According to the Oklahoma Birth Defects Registry, in 2010 $110 million was spent on babies with birth defects in Oklahoma hospitals. It is possible that taking Zofran caused many of those defects, as it is the top selling morning sickness drug in the US. The first lawsuit against GSK, for illegally promoting Zofran for morning sickness, was filed in 2015 after which hundreds of families have followed suit.
If you or a loved has a child born with health defects and you took Zofran during pregnancy, it is possible to file a lawsuit against GSK. AMA Law has a team of experienced attorneys who have dealt extensively with dangerous drug cases. They can go over you and your child’s medical history to determine if you are eligible and provide you with the best legal representation in Oklahoma and beyond. To speak to one of our attorneys about Zofran and its side effects, contact AMA Law today.