Studies Highlight Zofran Birth Defect Risk
Zofran (ZUPLENZ ®) is a drug used to treat nausea and vomiting in those undergoing cancer treatments, such as radiation and chemotherapy. It is also sometimes used to help those who suffer nausea from anesthesia following surgery. Zofran has also been prescribed to pregnant women suffering from morning sickness. GlaxoSmithKline marketed the drug as a remedy for morning sickness, even though it was not approved by the Food and Drug Administration for that specific purpose. As a result, many babies have been born with serious and debilitating birth defects.
Brand Names: Zofran, Zofran ODT, Zuplenz
Research conducted by the US Centers for Disease Control has shown that women who used Zofran during pregnancy were more than twice as likely to have a baby born with cleft palate. Another study, conducted by the University of Western Australia, showed that women exposed to ondansetron – the active ingredient in Zofran – increased the prevalence of birth defects by 20%. Babies were also six times more likely to develop malformed kidneys. A Danish study found that babies exposed to ondansetron while in the womb were nearly five times more likely to develop congenital heart defects.
What is Zuplenz?
Zuplenz (ondansetron) blocks the actions of chemicals in the body that can trigger nausea and vomiting.
Zuplenz is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation).
Zuplenz is not for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.
GlaxoSmithKline started receiving reports of birth defects more than 20 years ago. In 2012, the company faced criminal charges for illegally promoting Zofran for unapproved uses, including treatment of morning sickness. The company paid $3 billion to settle claims. But, the company’s legal battles are far from over.
Another lawsuit was filed earlier this year. Since then, seven other women have come forward with claims that Zofran use caused their babies to be born with birth defects. The alleged birth defects include cleft palate, heart defects, fluid on the brain, heart murmur and developmental delays.
GlaxoSmithKline does not warn Zofran users about birth defects, despite the fact that the company has received more than 200 complaints. Numerous lawsuits allege the company pays doctors to prescribe it to pregnant women. In addition, the lawsuits allege that the company knew about these possible risks, but failed to inform physicians and patients. Prior to Zofran approval, the company performed testing on rodents and rabbits and found that ondansetron caused intrauterine death and fetal malformations.
Pharmaceutical companies have a duty to create safe drugs and to sufficiently warn consumers and patients of all known side effects and risks. If you or someone you know used Zofran while pregnant and delivered a child with a birth defect, contact Nadrich & Cohen, LLP today for a free consultation.