FDA Petitioned to Ban High-Dosage Opioids

By Paul Gaita 09/05/17

The citizen petition has earned the support of former drug czar Michael Botticelli.

Man holding a pill.

A coalition of health professionals and families of opioid overdose victims have created a citizen petition that calls for the Food and Drug Administration (FDA) to remove ultra-high dosage opioid medication from pharmacies.

The petition's signatories, which include the National Safety Council, Physicians for Responsible Opioid Prescribing, and the American College of Medical Toxicology, seek a ban on opioid medication that exceed 90 MME (morphine milligram equivalent) per day—including OxyContin's 80 milligram tablet and IR (immediate release) oxycodone 30 milligram tablets—which according to the Centers for Disease Control and Prevention (CDC), can greatly increase the risk of dependency and/or overdose, which is at the heart of the national opioid epidemic. Per federal legislation, the FDA is required to rule on the petition within 180 days.

The petition claims that while opioid doses above 90 MME per day—also know as ultra-high dosage unit (UHDU) opioids—can be applicable in cases of "severe pain from a life-limiting illness," the risks associated with such high dosages far outweigh any possible benefits. Chief among these is the risk of dependency. As the CDC notes, even individuals taking relatively low doses of prescribed opioids are "15 times as likely to develop an opioid use disorder as a person who has not been prescribed opioids." For dosages of 120 MME per day or higher, the CDC has stated that the chance of dependency could rise to 122% greater than those not on opioids.

Pulling UHDU opioids from shelves could also reduce life-threatening incidents among those who misuse prescription opioids or take them for recreational purposes or—as is often the case in adolescent or toddler morbidity and mortality cases—by accident; doses above 50 MME carry twice the potential for overdose than those at 20 MME.

Eliminating them from the market could also change prescribing methods, as Dr. Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing and a signatory on the petition, suggests. "The thinking early on was, as patients became tolerant, you respond to tolerance by giving even more," he said to CNN. Removing the option for UHDU could curb tendencies towards prescribing higher doses, which as the petition opines, "became normative over the past 20 years."

The petition has earned the support of Michael Botticelli, former director of the White House Office of National Drug Control Policy (ONDCP) under President Barack Obama. "We clearly know that high dosage increases the probability of addiction," said Botticelli, who also has a personal history of substance dependency. "Where we have products that are dangerous, it's important to call for their removal. It is equally as important as doctor prescribing behaviors."

But opposition has also been voiced in regard to the petition. Dr. Steven Stanos, president of the American Academy of Pain Medicine, suggests that doctors can reduce the need for high-dose prescriptions by first examining how the medication is affecting the patient beyond pain relief. "Assess depression, anxiety, all these other types of social variabilities," he said. "If they're thinking of just the morphine dose, they're going to forget these other factors that are patient-specific."

Removing UHDU also could have the potential to negatively impact both patients and the physicians seeking to assist with their pain relief. "We want to be helpful as we can as pain physicians, and turn the curve on overdose deaths," said Stanos. "But we don't want patients to feel stigmatized... we don't want physicians to feel like they can't use opioids appropriately." 

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.