Darvon regulatory update

Xanodyne will withdraw its propoxyphene-containing pain drugs at FDA's request after new data showed the drugs increase the risk for serious abnormal heart rhythms. A new safety study conducted by Xanodyne showed that propoxyphene produced significant changes to the electrical activity of the heart, including prolonged PR and QT intervals. FDA requested the safety study last year, when it allowed the drugs to remain on the market with a boxed warning despite a recommendation for withdrawal from an advisory committee (see BioCentury, July 13, 2009). ...