PROP Petitions FDA to Remove High Dose Opioids from Market

When the members of PROP failed to convince the FDA to limit access to prescription extended-release opioids to people in only ‘severe non-cancer pain’ (although they did claim partial success due to the labeling changes which the FDA did amend) they did not give up the fight. They changed tactics.

Instead, they tried to mechanically limit opioids to those truly most in need of them by demanding that higher dosages . . . just stop being produced at all. They filed another ‘citizen’s petition’ to the FDA in September of 2017. What dose is too high, according to PROP? Any dose that when taken as directed exceeds 90 morphine milligram equivalents per day, because that’s the dose which the CDC declared to be ‘dangerously high’ according to PROP’s fact sheet. The CDC declared anything over 90 MME to be dangerously high … but how did the CDC reach that conclusion?

The CDC decided that anything above 90 MME was ‘dangerously high’ because PROP helped to author that guidance, even with very low quality evidence.

It’s a small percentage of patients who actually require higher doses opioids, but they exist and they would be impacted. There is some excellent coverage about about what types of patients require the ‘ultra high doses’ and still more about the types of genetic anomalies which impact one’s ability metabolize drugs.

Pharmaceutical opioid analgesics are produced in a wide variety of doses to enable discrete and specific treatment of the vast expanse of pain types and levels suffered by humanity. We need more choices and flexibility, not less.

Allowing PROP to dictate the parameters by which chronic pain – or any pain – is treated is ridiculous. PROP’s efforts have already caused untold harm to millions of people, and PROP’s members continue to work to influence policies about pain treatment in a number of areas. Watch this space.