I know many of you who take Darvon or Darvocet have been concerned ever since the FDA announced that it was considering a Public Citizen petition to remove these and other drugs containing propoxyphene from the market due to the high risk of overdose in patients taking them. You'll be relieved to know that, for now at least, the FDA has denied the petition and decided to leave the drugs on the market with increased warning labels.
In their response to the petition, the FDA noted that despite their serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time. They also noted that they plan to further evaluate the safety of propoxyphene and will take additional regulatory action if necessary.
In an effort to better protect patients and further evaluate the risks vs. benefits of propoxyphene, the FDA is doing several things:
• It is requiring manufacturers to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products.
• Manufacturers will be required to provide a medication guide to patients stressing the importance of using the drugs as directed.
• They are requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses.
• To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.
Propoxyphene manufacturers have 30 days to submit the requested safety labeling changes to the FDA or to provide a reason why they do not believe such changes are necessary. If there is any disagreement between manufacturers and the FDA, there will be a period of discussion after which the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.
Published On: July 08, 2009