Health Groups Petition FDA to Pull High-Potency Opioids

In response to the growing opioid abuse epidemic, several health groups have written a petition requesting that the FDA remove ultra-high dosage unit (UHDU) analgesics from the market.

The 5 groups—the National Safety Council, Physicians for Responsible Opioid Prescribing, the Association of State and Territorial Health Officials, the American College of Medical Toxicity, and FED UP! Coalition to End the Opioid Epidemic—supported their petition by citing a CDC guideline in which opioid doses exceeding 90 morphine milligram equivalent (MME) per day were deemed to be “dangerously high.”

Opioids that cross this threshold when taken as directed include UHDU formulations of oxycodone, morphine, hydromorphone, oxymorphone, methadone, and transmucosal fentanyl, according to the petition.

The groups specifically pointed to a CDC-conducted study in which patients who used between 50 and 100 MME per day faced a 1.9 to 4.6 times greater risk of addiction than those who used less than 20 MME/day. The CDC also suggested that opioid dosages exceeding 50 MME per day increased the risk of overdose without adding a comparable benefit to pain control.

“The harms of UHDU orally administered opioid analgesics outweigh the modest benefit of allowing patients to swallow fewer tablets or capsules,” the petition concluded. “When utilizing the new benefit-risk framework that takes into account inappropriate use, the need for removal of UHDU becomes even more clear. UHDU opioids should be immediately removed from the market to prevent further harm to thousands of adults, adolescents, children and toddlers.”

The petition was issued the same week that CDC officials awarded more than $28.6 million in additional funding to 44 states and the District of Columbia to support their responses to the opioid overdose epidemic. The CDC funds build upon the July 2017 announcement that CDC was providing $12 million to states to support overdose prevention activities.

At PainWeek 2017, Society of Palliative Care Pharmacists President Rabia Atayee, PharmD, told Pharmacy Times that while she agreed that opioid abuse is an urgent concern, she did not necessarily believe that removing high-potency opioids from the market would be the best way to combat the epidemic.

“I think that what’s more important is that, as clinicians, we’re trained to use opioids at any dosage appropriately,” Dr. Atayee said. “This epidemic is the result of health care providers failing to properly dose and monitor their patients. Let’s put our efforts together in an interdisciplinary approach and train providers to accurately assess their patients rather than pulling certain drugs from the market, because there may be cancer patients or others who are truly benefiting from these high-dose opioids.”