Pregnant women experiencing morning sickness should be aware of a potential link between Zofran and birth defects.
The anti-nausea drug was approved by the U.S. Food and Drug Administration (FDA) in 1991 to treat nausea and vomiting caused by radiation and chemotherapy. Although the drug was never approved for use in pregnant women, GlaxoSmithKline (GSK) promoted the treatment of morning sickness as an off-label use for Zofran.
More than 20 years later, doctors learned about the potential link between Zofran and birth defects.
A 2012 study published in the Center for Birth Defects Research and Prevention found that Zofran pregnancy use doubled an unborn child’s risk of developing cleft lip or cleft palate.
A separate Danish study suggested Zofran use during pregnancy could increase the possibility of a child being born with heart defects.
GSK failed to warn pregnant women, doctors and the general public about the potential link between Zofran and birth defects. In 2012, the pharmaceutical giant agreed to pay $3 billion to settle civil and criminal charges involving actions such as unlawfully marketing certain drugs and withholding data from the FDA. The Illegal marketing of Zofran to treat morning sickness was included among the charges.
Anapol Schwartz Personal injury lawyers are currently filing claims on behalf of children born with facial and heart defects, because GSK failed to warn about the link between Zofran and birth defects. If your family was adversely affected by Zofran pregnancy use, you may be eligible to file a Zofran birth defects lawsuit.