After reviewing new data demonstrating that the painkiller propoxyphene (marketed as Darvon and Darvocet) significantly increases the risk of possibly fatal heart arrhythmia, the FDA has requested Xanodyne Pharmaceuticals and other companies making generic versions to remove the drug from the market. The pharmaceutical companies have agreed.
Though the FDA has received two previous requests for a recall of Darvon, the agency decided as recently as July 2009 to let the defective drug remain on the market, albeit with strong warnings. At the same time, the FDA ordered Xanodyne to conduct further scientific testing of the drug’s side effects. The results of that study, which showed that propoxyphene harms the heart’s electrical activity even at normal doses, prompted the FDA to ask for a recall of the drug last week.
Consumer advocate groups, such as Public Citizen, have roundly criticized the FDA for not recalling Darvon in the US more quickly after it was recalled in the UK six years ago and more than one year ago in Europe. Public Citizen estimates that approximately 120 million prescriptions for propoxyphene have been filled in the US, potentially resulting in thousands of deaths, since the UK’s ban in 2004.