Zofran is a pharmaceutical drug that was initially used during cancer treatments preventing nausea and vomiting during chemotherapy. Zofran has the generic name Ondansetron and has been marketed to treat morning sickness in pregnant women as well. In 2012 the manufacturer GlaxoSmithKline paid a 3 billion dollar fee for failure to report safety data and intently marketing the drug “off brand name.” The drug was marketed under its generic name and was prescribed to pregnant women to treat their morning sickness. Studies reveal that Zofran is currently being linked to life-threatening birth defects. There is no warning label citing these possible birth defects.
Odansetron Hydrochloride (Zofran’s off-brand name) is a serotonin receptor which cannot be used along with many other drugs and vitamins that block serotonin. There have been multiple studies performed on Zofran. Some studies show an increase as high as 30% greater by consuming the drug earlier than 10 weeks pregnant. In 2011 the FDA issued a warning that Zofran may cause a heart defect called QT Interval Prolongation which can lead to the serious condition called Torsade de Pointes. Torsade de Pointes is seen as a twisting line during an ECG screening. The lines appear twisted, jagged and will suddenly terminate but often recur without warning. The symptoms are shortness of breath, chest pain, pounding heart, and fainting which can be terrifying to children born with the defect. The link between Zofran and these heart defects are still being studied by the FDA, Universities, and the manufacturer GlaxoSmithKline. However, the FDA enforced proper labeling of the possible side effect if the drug is taken with other heart medicines and even with vitamins containing magnesium.
There are over 19,000 reported claims that vary from heart defects, sepsis and craniosynostosis. These claims are itemized and categorized for further research and rebut. The manufacturer could be negligent in marketing the product to pregnant women without proper studies or warnings. However, the product is not banned and is still actively prescribed throughout the world.
Our law firm is dedicated to helping people from all walks of life. If you or a loved one believe you have a claim against Zofran then do not hesitate to call us. We are a people first law firm and believe in justice being served. 1-888-WE-MEAN-IT.