Alameda County, California, parents have filed a lawsuit against GlaxoSmithKline (GSK) for a heart defect their daughter suffered allegedly as a result of the mother being prescribed Zofran (ondansetron) while pregnant.
This medication is used to prevent nausea and vomiting caused by chemotherapy and radiation therapy and is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body’s natural substances (serotonin) that causes vomiting, according to WebMD.
The girl was born in 2007 with severe congenital heart malformations and had to undergo numerous examinations culminating in surgery at age four. The lawsuit alleges that the child’s injuries would not have occurred if GlaxoSmithKline had not concealed the risks of taking Zofran during pregnancy. The parents said, “it has been a long struggle to address damage to her heart that we believe was caused by Zofran.” They filed the lawsuit, in part, to raise awareness of the dangers of Zofran.
Zofran was approved by the U.S. Food and Drug Administration (FDA) to treat severe nausea caused by chemotherapy or radiation treatments in cancer patients. But GSK marketed Zofran “off-label” as a safe and effective treatment for nausea and vomiting suffered during pregnancy—morning sickness.
In 2012, GSK pled guilty to criminal charges filed by the U.S. Department of Justice for its off-label promotion of certain prescription drugs, including Zofran, for uses never approved by the FDA. Zofran, however, continues to be widely prescribed to pregnant women across America to treat morning sickness even though it is not approved for this use.
“Despite having received hundreds of reports of birth defects associated with Zofran and continuing strong sales to pregnant women, GSK has not performed any clinical studies on the safety or efficacy of Zofran for treating morning sickness,” according to one of the attorneys representing the girl’s family. The attorney also said GSK has not updated Zofran’s labeling to warn doctors and pregnant women that epidemiological studies report an increased risk of birth defects in infants exposed to Zofran during pregnancy. Recent studies report that a mother exposed to Zofran had more than double the risk of having a baby with a congenital heart defect compared to a mother who did not take Zofran during pregnancy. In addition, some parents have filed lawsuits alleging Zofran caused their child’s cleft lip or cleft palate.
The lawsuit was filed last week in federal court in San Francisco. The lawsuit claims negligence, misrepresentation, concealment, breach of warranty, and violations of California law. The parents seek compensatory and punitive damages from GSK.