The FDA is requiring revised labeling to help reduce the risk of an overdose in patients using pain medications such as Darvon (propoxyphene napsylate) and Darvocet (propoxyphene napsylate plus acetaminophen) because of data linking propoxyphene to fatal overdoses. A widely prescribed opioid, propoxyphene has been sold since 1957 as a therapy for mild-to-moderate pain.
Makers of propoxyphene-containing products are required to strengthen the label, including the boxed warning, emphasizing the potential for an overdose when these products are used. The companies must also provide a medication guide for patients to emphasize the importance of using the drugs as directed.
At this time, the FDA does not plan a phased withdrawal of propoxyphene, stating that the benefits of using these medications for pain relief at recommended doses outweigh the risks; however, further evaluations are anticipated.
Source: FDA, July 7, 2009