Cleft palate is the fourth most common birth defect in the United States, and is more likely to appear in babies of Asian, Latino and Native American decent. Twice as many boys have cleft palate — which occurs when tissue in the palate of the mouth doesn’t connect — as girls, while twice as many girls have cleft lip — which occurs when lip tissue does not connect — compared to boys.
Cleft defects have been linked to several medications, including the anti-nausea drug Zofran. Studies have found that women who use drugs such as Zofran during pregnancy could be at an increased risk of giving birth to a child with cleft palate defects by as much as 200%.
Children born with cleft palate or cleft lip may require several surgeries and bone grafts to fix the defect. Several patients who took Zofran while pregnant and gave birth to a child with cleft defects have begun filing Zofran lawsuits against the drug’s manufacturer, GlaxoSmithKline.