Families who filed lawsuits against GlaxoSmithKline say a new label for Zofran (ondansetron) shows the drugmaker could have warned about birth-defect risks sooner.
The new label links the anti-nausea drug to cardiovascular and cleft-palate birth defects for the first time.
The previous label didn’t include warnings about those possible side effects because, according to GSK, the language wasn’t approved by the U.S. Food and Drug Administration (FDA), Law 360 is reporting.
The FDA only approved the drug to treat nausea and vomiting in chemotherapy, radiation and surgery patients.
