FDA unveils new labeling rules for opioids

pill bottlesUnder pressure from activists and other critics, the U.S. Food and Drug Administration on Tuesday announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin.

According to the agency, the changes are aimed at combatting “the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities.”

The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.

The FDA’s move was met with skepticism by some activists who were concerned the changes do not go far enough. Pete Jackson, the president of Advocates for the Reform of Prescription Opioids, said the development could be viewed as either a step in the right direction or as “another smokescreen put out by the FDA to make it look like they are doing something.”

“They still authorize the use of opioids for long-term chronic opioid therapy, they have not addressed immediate-release opioids such as Vicodin, they still have not addressed the misclassification of hydrocodone combination products, and they still have a weak and voluntary prescriber education program,” he said. “Thus, regardless of how one views this labeling change, they are sitting on a lot of important actions that could save lives.”

About Erin Marie Daly

I’m a freelance journalist based in San Francisco. My book on prescription drug and heroin addiction was published in August 2014 by Counterpoint Press.
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3 Responses to FDA unveils new labeling rules for opioids

  1. Kevin says:

    The FDA is a joke. They are directly responsible for authorizing these killer drugs in the first place because they trusted Purdue Pharma. This approach is about as effective as putting notices on cigarette packs that cigarettes may be harmful to your health. People who are addicted to nicotine are going to use them anyway.

    It is amazing that the Federal government is so concerned about “1500 innocent civilians” getting slaughtered in another Syria when lazy FDA bureaucratic slugs are directly responsible for tens of thousands of American Oxycontin deaths because they couldn’t be bothered to study the faulty test results that Purdue Pharma, owned by the Sackler Family, provided them with.

    FDA: “Federal Death Authority”. We are the families of painkiller victims and we will be voting in the upcoming elections.

  2. iamaviewer says:

    Stay out of my doctor patient relationship. Control the drugs on the street–that’s where the abuse takes place. Either that or let me show you what just a week with awful pain is, and see how fast you change your tune.

  3. Merlin Klotz says:

    Anti-Oxycodone advocates may have succeeded in moving my wife to Hospice and morphine. She is bed bound and in 24 hour pain due to MS. Oxycodone every 4 hours around the clock does mitigate her pain.

    With Obamacare death panels she will max out her allowable dollars quickly so availability of Oxycodone may not be a long term problem for her… no thanks to the fickle FDA and the nut cases they listen to.

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