FDA Warns About Cancer Pain Drug Fentora

From HealthDay.com:

Due to recent reports of deaths and other problems associated with the cancer pain drug Fentora (fentanyl buccal) tablets, the U.S. Food and Drug Administration on Wednesday issued a warning about the drug to doctors and patients.

Fentora is a powerful opioid pain drug used only for the treatment of breakthrough pain in cancer patients who no longer respond to standard opioid pain treatment, the FDA said….

The agency reminded doctors and other health professionals that it is critical to follow product labeling when administering Fentora, and that it’s dangerous to use Fentora for any short-term pain such as headaches or migraines. Fentora must not be used in patients who are not opioid tolerant.

Emphasis added.

Fentanyl is very nearly a wonder drug for very short-term pain relief, given IV, in the Emergency Department.  Predictably short onset, short half-life, then they’re back to baseline.  (And it seems to make everyone want to scratch their nose while ‘out’, which is a little amusing).

Fentanyl in the patch form is also a good adjunct for pain control win those with real, chronic pain (cancer patients, usually, but there are others).  Usually patients come to the ED when one gets destroyed, or they run out over a long weekend.  I’m not sold on starting these patches on patients in the ED, so I don’t.

While I see the utility of an oral fentanyl tablet, I’d be the last to give it to anyone.  I have no idea the variability of dosing from person to person.  How much does a dry mouth decrease or increase their intake?  At least with a patch there’s some baseline for dose delivered.

We’re always looking for better ways to treat real pain in the ED, but this confirms it’ll have very little use in any ED.


  1. I think there’s been some good studies assessing buccal liquid sufentanyl for palliative patients who are too ill to swallow but who don’t want to be taking injectable meds.

  2. I’ve discharged a few patients after applying one low dose fentanyl patch to give them some additional pain relief and help reduce their hydrocodone requirement until they can get in to see their own physician for more appropriate management. Not often though.

    It’s just another arrow in the quiver, useful in selected situations.