Popular Posts

Thursday, August 02, 2012

Tighten Opioid Label Restrictions, Physicians Tell FDA

A coalition of 37 physicians that includes pain management and addiction experts petitioned the US Food and Drug Administration (FDA) yesterday to tighten label restrictions for opioid analgesics as a way to combat the epidemic of addiction and fatal overdoses associated with these drugs.


Under the proposed label changes, opioids would no longer be indicated for moderate noncancer pain. The petition notes that moderate to severe pain is the FDA-approved indication for nearly all instant-release opioids as well as extended-release versions when 24/7 pain relief is needed for a long stretch of time. Such "overly broad indications" imply that the FDA has established that long-term use of opioids is safe and effective, the petition states. "An increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses."


In addition, the maximum daily dose would be the equivalent of 100 mg of morphine, and the maximum duration for continuous daily use would be 90 days under the proposed label changes. Both limits would apply to noncancer pain.


One of the petitioners, Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing, toldMedscape Medical News that the label changes would not prevent physicians from prescribing opioids at doses and durations that they deem appropriate for patients on a case-by-case basis. However, the changes would limit claims that drug companies can make about their products.


"Right now, drug companies are promoting long-term opioids as proven safe and effective for chronic pain," he said. "They'll promote [them] for lower back pain, fibromyalgia, osteoarthritis, whatever they want…because the current label is like a blank check."


Source

4 comments:

  1. I don't want to take drugs for my chronic pain. I wish I did not have chronic pain. I wish the drugs I do take were more effective. I wish the government would get the f out of the doctor's office and let them do their effing job.

    I wish they would end this silly ineffective 'war on drugs'. It's not working and they only target easy sitting ducks, like doctors and their patients.

    Stop using me and the other sufferers to justify your jobs.

    ReplyDelete
  2. I'm a nurse, this will ruin lives of innocent people seeking pain relief for multiple issues. I know a lot of people would rather die now then wait for death to come while in severe pain for many years. Some people have families and children that they need to care for but can't due to pain. This is just punishment for innocent people.

    ReplyDelete
  3. Why let the dope heads mess it up for the folks that trul;y need pain meds like long term chronic pain sufferers and cancer patients. i can only hope that the politicians and doctors that approve this have their own loved ones get cancer and die a painful slow death.

    ReplyDelete
  4. i can only hope that the politicians and doctors that approve this have their own loved ones get cancer and die a painful slow death.

    August 3, 2012 4:41 PM

    I don't think you are one of us. We know, we feel the pain.

    I don't think any of us would want to wish this on someone else.

    At least I don't and can only hope no one else will.

    ReplyDelete

Note: Only a member of this blog may post a comment.