Monday, January 22, 2018

AIPM’s Response to FDA’s Request to Pull Opana ER Off Market


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.”

See the FDA’s statement here.

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About The Academy

The American Academy of Pain Management improves the lives of people with Pain by advancing a person-centered, integrative model of pain care through evidence-guided education, credentialing, and advocacy.