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Groups petition FDA to remove certain opioids from market
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Several medical groups have joined forces to ask the FDA to remove what it calls “ultra-high dosage opioids” from store shelves, according to a press release.
“Sometimes these higher-dose opioids are appropriate in certain instances of chronic pain and cancer pain,” Jay Butler, MD, president of the Association of State and Territorial Health Officials, one of the groups signing the petition, told Healio.com/Family Medicine in an interview. “But in other instances, when these high doses are in a single pill, the user may not be aware of how much opioid is in the pill.”
Ultra-high dosage opioids include the OxyContin 80 mg tablet, which is equivalent to 24 regular strength Vicodin in one pill, according to the release. CDC data indicate that the opioid crisis is responsible for 91 deaths each day.
Butler said the FDA’s recent withdrawing of its approval of Opana ER suggests the time is right for a petition to be put before the FDA.
He also referenced a National Academies of Sciences, Engineering, and Medicine report that, among other things, recommended the FDA review of the safety and effectiveness of drugs in light of public health effects, not just the safety profile for the individual patient taking the medication as directed.
Other groups supporting the Association of State and Territorial Health Officials petition include Physicians for Responsible Opioid Prescribing, the National Safety Council, and the American College of Medical Toxicology.
Butler noted that other alternatives rather than complete removal of the opioids would need to be thoroughly vetted by the FDA.
“Looking at the cost and benefits, removing the ultra-high dosage opioids may be the easiest and safest option,” Butler said in an interview. “Relabeling opioids and requiring additional safeguards would be other options, but I would have to defer to the FDA and its judgment on those matters.”
The petition can be viewed on the FDA’s website. Comments are due by Feb. 28, 2018 at 11:59 PM EDT. – by Janel Miller
For more information: “Citizen Petition from Physicians for Responsible Opioid Prescribing.” Available at: https://www.regulations.gov/document?D=FDA-2017-P-5396-0001. Accessed Sept. 6, 2017.
Disclosure: Butler reports no relevant financial disclosures.