Tuesday, July 12, 2005
The FDA announced a new warning label for Duragesic (transdermal fentanyl patch) today. Most of it is pretty straightforward, reasonable stuff--a little bit of it dumbfoundingly basic (avoid concomitant use of alcohol, etc). The bulk of the warning seems to be about not using duragesic in opioid naive patients and that patients should have proven tolerance to moderate doses of opioids--60mg of morphine a day for instance. This is probably a good thing: I have seen several opioid naive elderly people put on the 25mcg/hr Duragesic patch for chronic pain because it's "such a low dose." The prescribing doctors would never have considered starting MSContin 30mg bid in these patients. The .pdf of the release is here.