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Health Officials and Docs Petition FDA to Take High-Dose Opioids Off Market
A group of public health officials and doctors have filed a “Citizen Petition” with the Food and Drug Administration (FDA) asking the agency to remove ultra-high dosage unit (UHDU) opioid painkillers from the market.
The petition specifically targets oral and transmucosal painkillers providing an average of 90 milligrams of morphine equivalent (MME) or higher in a single dose. Opioids of this strength, says the petition, outweigh any benefits by increasing the risk of addiction and overdose.
In fact, the Centers for Disease Control and Prevention (CDC) already has determined such dosages to be “dangerously high,” the petition said.
The petition points out that in 2015, roughly 11.5 million Americans misused prescription opioids, and half of all overdose deaths that year involved prescription opioids. Because the trend continues at dangerous levels, the petition says immediate action is called for.
A dangerous example – OxyContin 80mg ER
The petition gives OxyContin 80gm ER (extended release) as an example of an ultra-high dose.
To quote the petitioners:
“An example of an extended release (ER) UHDU opioid is the OxyContin 80 milligram tablet. A patient directed to take one tablet twice a day is consuming 160 milligrams of oxycodone per day, which is equal to 240 MME/day and far greater than the CDC’s recommended 90 MME/day upper dose. Because only one pill is taken at a time, the patient and prescriber may not appreciate that this is an extremely high dose.”
An example of an immediate release (IR) opioid painkiller that qualifies as UHDU is oxycodone 30mg tablets, typically taken four times a day. When oxycodone 30mg is taken as prescribed the total daily dose is 120mg of oxycodone, which is equal to 180 MME. Obviously, the current recommended medical dose of four a day far exceeds the CDC’s recommended 90 MME.
The petition points out that there are many such painkillers on the market.
Why the FDA should listen to these petitioners
The petitioners represent some of the most influential agencies in the country, who speak for countless public health professionals across the country – the very people who are involved in the exhausting daily struggle to subdue the country’s out-of-control opioid epidemic.
- Jay Butler, MD, President, Association of State and Territorial Health Officials, and Director of Public Health, Alaska Department of Health & Social Services
- Deborah A.P. Hersman, President & CEO, National Safety Council
- Andrew Kolodny, MD, Executive Director, Physicians for Responsible Opioid Prescribing
- Charles McKay, MD FACMT, President, American College of Medical Toxicology
- Judy Rummler, Chair, FED UP! Coalition to End the Opioid Epidemic
And the petitioners claims are supported with a huge list of very impressive references.
Research proves that prescribing opioids can cause opioid use disorder.
The petition makes it especially clear that one of the most serious “adverse events” associated with high dosage opioids is development of opioid use disorder (OUD). Research shows that people taking even low doses of prescribed opioids “are 15 times as likely to develop an OUD as a person who has not been prescribed opioids.”
And as the dosages increase, so does the risk increase. At high doses equal or greater than the 120 mg MME, a person’s risk of developing OUD “is 122 times that of a person who has not been prescribed opioids.”
Just to make this clear: Some people with OUD have never been prescribed opioids by a doctor. But for every one of them, 15 more with OUD have been prescribed low-dose opioids, and as many as 122 more have been prescribed high-dose opioids.
With professional as well as financial resources strained to the limit, the time to act is now, in every way possible. Here at Novus, we believe that more resources and more attention to physician opioid prescribing habits is needed, if we are going to get a handle on the opioid epidemic.
If you or someone you care for has a problem with drugs or alcohol, don’t hesitate. Call us today.
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