A study published by the Center for Birth Defects Research and Prevention in 2012 suggested that women who took Zofran® during the first trimester of pregnancy had a twofold increased risk of having a child with cleft palate or lip.
A separate Danish study found a possible link between Zofran and heart defects.
The U.S. Food and Drug Administration (FDA) approved Zofran in 1991 to treat nausea and vomiting associated with radiation and chemotherapy.
Due to heavy off-label promotion by GlaxoSmithKline, Zofran became a popular treatment for morning sickness. Doctors expected the anti-nausea drug would benefit the patient, but little information was provided about the effect on the unborn child. GSK failed to warn about the link between Zofran and birth defects and is now facing multiple lawsuits.
In 2012, the company paid $3 billion to settle criminal and civil charges of unlawful behavior which including withholding safety information from the FDA and illegally promoting the off-label use of Zofran and other popular drugs.
Women who took Zofran during the first trimester of pregnancy and had a child with heart defects or cleft lip and/or cleft palate facial deformities may be eligible to file Zofran birth defects lawsuit.
GSK took responsibility for the charges filed by the Justice Department. Families affected by the company’s failure to warn about Zofran birth defects also deserve justice.
Women may be eligible to file a Zofran birth defects lawsuit if the drug was taken to treat morning sickness during the first trimester and their unborn children developed cleft palate, cleft lip, or heart defects. Contact a Zofran lawyer to preserve your legal rights.