Chronic Pain — 19 September 2013

By Pat Anson, Editor

The Food and Drug Administration has announced long awaited labeling changes for prescription opioid medicines – changes that adopt many of the demands made in a citizens’ petition that called for major changes in the prescription guidelines for narcotic pain relievers.

The biggest change is that long term opioids would no longer be indicated for “moderate” pain.

The FDA said it was changing the labeling on all extended-release and long-acting (ER/LA) opioid painkillers “to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.”

The updated labeling will state that ER/LA opioids are indicated for the management of severe pain only — “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

It was over a year ago that a group of doctors and public health officials, led by Physicians for Responsible Opioid Prescribing (PROP), petitioned the FDA to change the prescription guidelines for opioids.

Current labeling approves most opioids for “moderate to severe pain,” but the petitioners said that was an overly broad definition that encouraged physicians to prescribe powerful pain medications to patients who don’t really need them.  They wanted the word “moderate” dropped from the labeling requirements, so that opioids would only be indicated for treatment of cancer pain and severe non-cancer pain.

The new FDA labels drop the word “moderate” and will say that ER/LA opioids should not be indicated for “as-needed” pain relief. However, doctors would still be able to prescribe opioids “off label” for moderate pain.

Read more at National Pain Report.


About Author

Pat Anson, Editor

Pat is Editor in Chief of American News Report. He is a veteran journalist and a former correspondent and producer for HealthWeek (PBS), Nightly Business Report (PBS) and other nationally syndicated shows. Pat has won numerous journalism awards, including a Golden Mike award for investigative reporting.

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