Response to FDA’s Request to Pull Opana Off Market

AIPM’s Response to FDA’s Request to Pull Opana ER Off Market – Academy of Integrative Pain Management Blog

On Thursday, June 8, the U.S. Food and Drug Administration “requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market,” the FDA said in a statement.

Apparently Opana ER, an extended release form of the opioid drug oxymorphone, was being crushed up and injected by people seeking to abuse it.

“After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”  

However, Bob Twillman, PhD and Executive Director of the Academy of Integrative Pain Management, doesn’t agree.

“As I told the FDA’s Advisory Committee in March, I think it is very poor practice to compare the benefits of a medication when used as intended by people with a legitimate medical need, to the harms suffered by people who intentionally defeat the safety mechanisms of the product so they can use it in ways that are not intended, and for something other than a legitimate medical need.

Opana ER, when used as intended by people with a legitimate medical need, has demonstrated no greater risk of harm than any other abuse-deterrent opioid, but because some people chose to go to great lengths to misuse it–and were harmed as a result–this medication will likely no longer be available for people with pain who benefited from it.

That’s unfortunate, it’s not fair to those people with pain, and it sets a dangerous precedent that could result in more market withdrawals for other products.”

I’m happy to see AIPM becoming more concerned and supportive of chronic pain patients needing opioids.

Beofre this, they had been suggesting all kinds of alternative quakery as pain “treatment” instead of opioids. They even went so far as to change their name to include “Integrative”, which is just a euphamism for unscientific alternative treatments.

I hope this is the start of a permanent change from their complacency about how pain patients are being treated.

Something or someone must have broken through to make them realize that they cannot call themselves medical doctors if they are withholding necessary and preoven effective pain relief from their patients and send them to reiki sessions or music therapy instead.

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5 thoughts on “Response to FDA’s Request to Pull Opana Off Market

  1. lawhern

    The following comment is awaiting moderation at AIPM:

    I am personally acquainted with a chronic pain patient for whom Opana ER has been a major savior of her life when she couldn’t tolerate other pain relieving medications. By taking Opana off the market when nothing else is available to take its place, the FDA may very well kill her.

    I encourage members and leaders of AIPM to take a MUCH more active public stance concerning the rank idiocy that is being forced upon chronic pain patients by the US government: CDC, FDA, DEA and I fear the President’s Commission on Combating Addiction and the Opioid Crisis. It is time for AIPM to publicly advocate for withdrawal of the March 2016 CDC Guidelines on prescription of opioids to adults with chronic pain. The Guidelines are demonstrably (and perhaps fraudulently) biased against opioid analgesics and the patients who have been stably and safely maintained on them for years. The Guidelines reflect weak medical evidence and unsupported opinion. And they dangerously ignore the medical science of opioid metabolism which renders any maximum dose limits totally inappropriate for poor metabolizers.

    In a spirit of outreach, I encourage your members to visit the National Pain Report and comment on a recent article there: “Warning to the FDA – Beware of ‘Simple’ Solutions in Chronic Pain and Addiction. http://nationalpainreport.com/warning-to-the-fda-beware-of-simple-solutions-in-chronic-pain-and-addiction-8833744.html

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      I can’t believe this is happening in the 21st Century. Kolodny and his pals at PROP should be sentenced to a life of chronic pain without the effective relief they are trying to take away from pain patients.

      Let them be so miserable and tortured by their pain that they want to commit suicide – but don’t let them. Force them to continue with each agonizing day until they suffer a “natural” and excruciating death.

      I haven’t felt such animosity for years as I try to practice mindfulness, but these guys are killing us!

      Even so, I’m going to try to ease the hatred I feel in my heart by using exercise and meditation – their recommended methods of easing pain. Let’s see if it works for the pain I’m feeling about what they’re doing.

      Liked by 1 person

      Reply
  2. Kathy C

    This was just a ridiculous attempt to make it appear they are doing “Something.” This stuff was marketed by the Company as “Tamper Resistant” and the cost was justified due to the Marketing. Apparently some Junkies found a way to inject it, and get around that Expensive “Deterrent.” This would have been an easy enough thing to check in a lab. Instead they were allowed to put this on the market. This Product was significantly more expensive than the Generic Equivalents. Pulling it from the Market, is just a Publicity Stunt, they have to appear to be doing something. We certainly won’t see the going after the Manufacturer for False Advertising, those days are over.
    We are truly Post Science and post Fact, this Pharma Products was not a problem, The Death Toll came out recently and the numbers of attributed “opiate deaths” are climbing. This was after they cracked down on the Prescription Drugs, cast all pain patients as “Addicts'” and ran a successful misinformation campaign in the Media. “Local News” is running Sensational Stories illustrated with Syringes, as they repeat the need for “Treatment.” Pharma funded Advertising with “Educational Tips” for the general public are run for free as “Informational” The Sensational and lurid Headlines, Billboards and Articles, appear to be adverting this, and make it more appealing.

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      I think you’re right – this is a publicity stunt to appear as though they’re “doing something”. It certainly doesn’t accomplish anything except torture and stigmatize pain patients even more.

      Liked by 1 person

      Reply
      1. Emily Raven

        Can confirm. I haunt the opiates Reddit and it’s actually very popular, like people are extremely happy when they can come by some (there’s pain patients in there too… I’m talking about the people that admit to rec use.) Apparently breaking it down is not that hard either and can be done with basic kitchen supplies. The formula was just to hold their patent.

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