Zofran, a widely-used anti-nausea medication, may be associated with fetal death when taken by pregnant women to control severe morning sickness. A number of studies have also indicated that the medication may increase the chances that a baby will be born with a serious birth defect if it is prescribed for the same purpose. Zofran has never been approved to treat expectant mothers, and its effect on a developing fetus has not been well-studied. In spite of this, evidence suggests that GlaxoSmithKline aggressively marketed the medication as a remedy for severe morning sickness.
The attorneys at Bernstein Liebhard LLP are investigating Zofran death claims and other lawsuits involving birth defects and pregnancy complications that may be associated with its use. If you believe your unborn child may have been harmed by Zofran, please contact our Firm today to learn more about the legal options available to you.
GlaxoSmithKline has been marketing Zofran in the U.S. since 1991, and its approved indications include:
The U.S. Food & Drug Administration (FDA) has assigned Zofran to Pregnancy Category B, which means no adequate or well-controlled studies have been conducted to determine if it can be safely taken by pregnant women. At the time of its approval, the limited fetal safety data provided by GlaxoSmithKline involved just 200 patients.
In July 2014, the Toronto Star reported that 20 Canadian women who had been prescribed Zofran or generic equivalents to control morning sickness had experienced serious pregnancy complications, including two cases of fetal death. In addition to the two possible cases of Zofran death, other problems detailed by the report included instances of heart birth defects, mouth abnormalities, kidney deformities, musculoskeletal defects, jaundice and poor fetal growth.
Even though Zofran has not been approved to treat morning sickness, doctors frequently prescribe the drug for this indication. While physicians are permitted to prescribe FDA-approved medications in any way they see fit, drug manufacturers are legally forbidden from promoting their products for uses that have not been approved by the agency.
In 2012, the U.S. Department of Justice announced that GlaxoSmithKline agreed to pay $3 billion to settle criminal and civil charges involving a number of medications, including Zofran. Among other things, the company was accused of promoting certain forms of Zofran for the off-label treatment of morning sickness in pregnant women, and of providing financial inducements to doctors to prescribe Zofran and other medications.
If you believe you lost your unborn child due to this medication, filing a Zofran lawsuit is one way you can hold GlaxoSmithKline accountable for your family’s pain and suffering. To learn more about your legal rights, and to arrange for a free, no-obligation case review, please contact Bernstein Liebhard LLP today by calling .