- Families Claim that Manufacturer Should Have Warned of Zofran Risks
- January 3, 2017
- Law Firm: Law Offices of Peter G. Angelos A Professional Corporation - Baltimore Office
The FDA approved Zofran, an antiemetic medication manufactured by GlaxoSmithKline (GSK) to prevent nausea and vomiting caused by cancer chemo therapy, radiation therapy, and surgery. Although Zofran was approved for distribution only for chemotherapy and radiation patients, GSK promoted the drug as an effective means to fight the same symptoms in pregnant women. Over the past 20 years, doctors have regularly prescribed the medication to expectant mothers suffering from morning sickness.
However, studies and reports continue to suggest a link between the consumption of Zofran by expectant mothers, and the development of congenital birth defects in children. Further, claims have been made suggesting that the company was negligent in failing to advise the public about dangerous side effects, despite evidence that GSK knew of an unreasonable danger to prenatal infants as early as 1992.
Over the past 4 years, numerous families and patients have filed Zofran lawsuits alleging the company failed to warn patients and doctors of the risks associated with the drug. Plaintiffs claim the drug caused birth defects, including cleft palate, cleft lip, and congenital heart defects.
Recent reports and patient claims suggest that GSK could have warned patients of the risks related to the medication earlier, but failed to do so. These claims are based on a newly released Zofran label that identifies the link between the drug and the potential for cardiac septal defects and cleft-palate birth defects. The label previously approved for Zofran did not include this warning.
Currently, GSK is facing hundreds of lawsuits regarding claims of the following:
- GSK had a responsibility to properly determine the drug’s safety before offering it on the market, and failed to do so.
- The company negligently failed to advise the public about dangerous side effects, despite evidence that GSK knew of an unreasonable danger to prenatal infants as early as 1992.
- GSK targeted pregnant women in advertising and marketing campaigns even though the drug was not FDA approved for use against morning sickness.
- All data and information regarding the safety of Zofran was not adequately assessed before releasing the drug to market.
- The company provided misinformation concerning animal studies alleging that Zofran was safe, when the side effects showed damage to bone formation.