On Tuesday the FDA announced it would not adopt a ban on propoxyphene (aka Darvon or Darvocet) at this time despite the advisory panel's recommendation that it do just that. The FDA said that based on the information currently available, the benefits of using propoxyphene as directed outweigh the risks. However, manufacturers will be required to strengthen package warnings and provide patients with a medication guide explaining the importance of taking the medication as directed. The FDA is also initiating a study of the safety of propoxyphene, which could lead to stricter regulation of the product. For now the agency believes providing patients with more information can improve safety without removing the product from the market.
FDA Takes Action on Darvon, Other Pain Medications Containing Propoxyphene
The agency's decision seems to indicate it is not yet convinced that such products are so dangerous they must be banned and is not likely to follow the advisory committee's recommendation to ban other prescription pain medications containing acetaminophen. Anything is possible, of course, but the situation seems much more promising than it did just a few days ago.
If you're interested in learning more, the FDA has provided a list of questions and answers here:
Propoxyphene Questions & Answers
FDA Advisory Panel Recommends Removing Certain Prescription Painkillers from Market
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Content by Diana E. Lee.
DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.