Zofran, or ondansetron, is a medication used to prevent nausea and vomiting that may be caused by surgery or cancer treatments such as chemotherapy or radiation. By the final year of its patent in 2006, Zofran had become the 20 th highest selling brand-name drug in the United States. However, in recent years a great deal of research has been conducted regarding the off-label use of the drug for the treatment of morning sickness during pregnancy and its potential link to various birth defects. Among these potential side effects are mouth deformities such as cleft lip and cleft palate, certain musculoskeletal conditions, and congenital heart defects. Numerous international studies have been performed investigating the link between the drug and these conditions with various results, however some articles have suggested that the incidence of these defects may be doubled due to the use of Zofran during pregnancy.
The manufacturer of Zofran, GlaxoSmithKline, paid a multi-billion dollar settlement in a civil action that alleged that the company improperly promoted this off-label use of the drug for expectant mothers. Recently, a number of lawsuits have been filed against GlaxoSmithKline for the injuries and defects that may have resulted therefrom, and the attorneys at Rourke and Blumenthal LLC are currently investigating these claims. If you or a loved one have potentially been harmed by the use of Zofran during pregnancy, please contact us today for a free consultation.