The FDA is also requiring a safety study that will assess the effects of propoxyphene on the heart when taken at higher than recommended doses. The FDA is leaving the door open to take further action, if necessary, based on the results of that study and other data. The FDA plans to work with several groups to study how often elderly patients are prescribed propoxyphene rather than other pain medications. They will also further evaluate safety profiles of propoxyphene compared to other pain medications.
For now, the FDA has concluded the benefits of pain relief, when taken at recommended doses, outweigh the risks. The FDA also denied a petition from Public Citizen that requested a phased withdrawal of propoxyphene. The opioid drug has been marketed for over 50 years and as it stands now -- it's staying. If you depend on the drug to manage your pain and if you were concerned about the FDA's decision, this news will come as a relief. Share your comments.
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