Should the FDA Drop High-Dose Opioids?

As the opioid crisis rages on, many ideas have been brought forward about the best ways to stem the tide of overdoses. The DEA suggested a 20% reduction in opioid production, abuse-deterrent formulations are becoming more popular (and may not work), and a wide swath of cities and states have tried suing opioid manufacturers.

Five 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-crafted a petition to the FDA asking for what they believe could help. According to the five organizations, the FDA should immediately remove ultra-high dosage unit (UHDU) opioids from the market.

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Jay Butler, MD, President of the Association of State and Territorial Health Officials and one of the petition’s co-authors, told Drug Topics that his goal was “not trying to take medications away from people,” but to balance the needs of patients with the threats of abuse. He said that the goal of the petition was to encourage the FDA to do more research into the issue, something that smaller states-Butler is also the Director of Public Health in Alaska-do not have the resources to perform.

According to the CDC, doses that exceed 90 MME/day are considered “dangerously high.” UHDU opioids, according to the authors; these are opioids that exceed that threshold when taken as directed. The extended release OxyContin 80 mg tablet is taken twice per day, resulting in 160 mg/day, which is 240 MME/day. Immediate release oxycodone 30 mg tablets are often taken four times per day, resulting in 120 mg/day or 180 MME/day. The authors call for the removal of those two formulations, along with high-dose versions of IR and ER hydromorphone, IR and ER morphine, IR and ER oxymorphone, ER hydrocodone, methadone, and IR transmucosal fentanyl.

The authors cite several other possible risks associate with UHDU opioids. The CDC found that higher MME per day can increase the likelihood of addiction-rates of addiction for patients using between 50 and 100 MME/day were 1.9 to 4.6 times greater than patients using less than 20 MME/day. The CDC added that increasing doses beyond 50 MME/day increased the chances of opioids while adding little benefit.

The authors also said that UHDU opioids increased risks for recreational users, giving the example of an opioid-naïve person experimenting and possibly fatally overdosing off a single dose. Beyond this overdose risk, the authors said, UHDU opioids have been linked to increased risk for motor vehicle accidents, fractures from falls, immune suppression, and opioid-associated androgen deficiency-which can lead to many other problems.

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Removing UHDU opioids from the market would not, the authors say, cause harm to patients or the health-care system as a whole. For patients, such as those facing painful, life-threatening illnesses or for those who have difficulty swallowing pills, the authors mention that multiple formulations are available, such as liquid preparations or patches.

Butler said that the UHDU opioids issue is “just one part of an overall response of what the FDA can be doing to help address the opioid crisis.” However, he added “addressing the particular threats from UHDU opioids is an important part of what the FDA can do to use the new paradigm for evaluating drug safety, which includes not only patient safety issues but also risks to the community.”