Why the FDA shouldn’t change the labeling of opioid analgesics?

Bob Twillman is a psychologist who works with pain patients.  He doesn’t write opioid prescriptions. He has long been involved in both Cancer Pain Initiative and the Pain Initiative Movement. He has been a guest blogger of on a number of occasions. (For transparency, is a web site run by Stewart Levitt, PhD with unrestricted educational grants from three pharma companies). A favorite of these blog was Bob’s review of the CDC’s report, “Vital signs: Overdoses of Prescription Opioid Pain Relievers-United States, 1999-2008.”

Dr Twillman has written a very considered response to a recent petition asking the FDA to change the currently approved label for opioid analgesics. What does the petition request?

  1. Strike the term ‘moderate” from the indication for noncancer pain
  2. Add a maximum allowable daily dose, equivalent to 100 mg of morphine for noncancer pain
  3. Add a maximum duration of 90 days for continuous (daily) use for noncancer pain.

Twillman addresses all of the data presented as evidence for the petition and insightfully “debunks” the evidence behind the petition. Bob’s blog is well worth the read!

I would be surprised if the FDA responded favorably to the petition. Why do I say this?  At a May, 2012 FDA meeting “Assessment of Analgesic Treatment of Chronic Pain; A Scientific Workshop,” FDA representatives stated in response to discussions on label change raised by the audience.

“Just to be sure you understand our position, we’re saying we can’t change the label unless somebody shows us data that convinces us that we should change the label.”

Based on Dr Twillman’s review (you can find it here), the petition does not show data that convinces me of the need for a label change!

Does it, for you?

About Pain policy & palliative care

Improving global pain relief by achieving balanced access to opioids worldwide


One thought on “Why the FDA shouldn’t change the labeling of opioid analgesics?

  1. No it doesn’t, and this is what angers me the most! These people are NOT pain management Doctor’s, they do not deal with patient’s like me that are in intractable pain, and that have found relief of long term opiod therapy. They jump in the band wagon just because it was something to do, not because they truly know what US chronic pain patient’s go through, and this is what angers me the most!

    Posted by Millie Andreasen | October 6, 2012, 6:14 PM

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