Zofran may be associated with birth defects and even fetal death
Research has suggested that the anti-nausea medication Zofran may be associated with birth defects and even fetal death among babies whose mothers consumed the drug to treat severe morning sickness. In fact, a number of studies have indicated that babies may have a higher risk of serious birth defects if they are exposed to the drug during the early stages of fetal development.
Zofran was approved by the U.S. Food and Drug Administration in 1991 as a treatment for vomiting and nausea in patients following surgery and undergoing certain cancer therapies. Zofran has not been approved for use in pregnant women as a treatment for the severe nausea and vomiting that may be experienced with morning sickness in pregnancy, yet physicians have increasingly been prescribing Zofran and its generic versions to pregnant women.
The attorneys at Bernstein Liebhard LLP are currently investigating Zofran death lawsuits and other claims involving allegations that Zofran makers marketing the drug to physicians as safe for use by pregnant women. These lawsuits also claims that Zofran causes birth defects including oral clefts, kidney abnormalities, musculoskeletal defects, and serious heart defects and fatalities. If you believe your child was harmed by exposure to Zofran during pregnancy, please contact our attorneys today to learn more about the legal compensation options that may be available to you.
Complications from Zofran Use During Pregnancy
Zofran, marketed by GlaxoSmithKline, was approved by the FDA for the specific use of preventing nausea and vomiting in:
- patients following surgery
- patients undergoing certain types of radiation
- patients undergoing certain types of chemotherapy
Zofran is categorized by the FDA as a Pregnancy Category B drug that has not been determined by controlled studies or adequate research as safe for pregnant women or babies. In fact, at the time it was approved for the U.S. market the only safety data available involved only 200 patients.
Investigations reported by the Toronto Star found that 20 adverse events reported by woman who used Zofran during pregnancy included two possible fetal deaths as well as cases of oral defects, heart defects, kidney defects, musculoskeletal defects, poor fetal growth and jaundice.
GlaxoSmithKline Settles Zofran Marketing Lawsuit
Drug manufacturers are prohibited from marketing medications for uses that have not been approved by the FDA.
Under U.S. law, physicians are legally allowed to prescribe medications for uses that have not been approved by the FDA, however, drug makers are prohibited from marketing their drugs to the public and medical providers for uses that have not been approved by the FDA.
In 2012, GlaxoSmithKline resolved criminal and civil allegations by the U.S. Department of Justice involving the illegal marketing of Zofran for off-label uses (those not approved by the FDA) including for promoting Zofran as a treatment for severe morning sickness in pregnant women. The DOJ also accused the drug maker of paying physicians kickbacks for prescribing Zofran and several other medication.
Legal Representation for Those Injured by Zofran
If you think that your baby was seriously injured or fatally harmed due to fetal exposure to Zofran, filing a Zofran death lawsuit will help hold drug giant GlaxoSmithKline accountable for injuries allegedly caused by use of their medications. To learn about filing a Zofran lawsuit and to schedule a free case evaluation, contact the attorneys at Bernstein Liebhard LLP today at 1-844-4-ZOFRAN.