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FDA Announces Opioid Safety Labeling Changes

Tuesday, September 17, 2013

On September 10, 2013, the Food and Drug Administration (FDA) announced safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioids.  These changes are consistent with ASA's recommendations to the FDA on labeling for ER/LA opioids.

The FDA also granted in part and denied in part the petition by Physicians for Responsible Opioid Prescribing (PROP), which requested that the following changes be made to opioid labels:

  1. Strike the term “moderate” from the indication for non-cancer pain.
  2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
  3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.

ASA had submitted recommendations to, and testified at public hearings convened by the FDA opposing each of the changes proposed by PROP.  The FDA cited ASA's opposition to the proposed labeling changes in their response to PROP.

In the FDA's response to the PROP petition, the Agency declined to add a maximum daily dose or duration of use for any opioid.  The FDA granted PROP’s request to strike the term "moderate" from the indication for ER/LA opioids.  However, in doing so the FDA stated that pain intensity alone should not be the only deciding factor guiding the initiation or maintenance of ER/LA opioids.  The FDA also emphasized the importance of patient functionality and quality of life in guiding prescribing decisions.

Specifically, the updated indication for ER/LA opioids provides that they are "indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."  This indication still permits a patient with moderate pain intensity to be a candidate for chronic therapy with an ER/LA opioid. 

Because of the risks associated with opioids, the updated indication further provides that these drugs should be 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 FDA is also requiring drug companies that manufacture these drugs to conduct studies and clinical trials to further assess the risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with the long-term use of ER/LA opioids.

Modifications to the safety labeling will be reflected in the FDA Risk Evaluation and Mitigation Strategy (REMS) for ER/LA opioids.  One key component of the REMS is the requirement that drug companies make available to health care professionals voluntary educational programs on safe opioid prescribing.   

Review ASA’s recommendations.

Review the FDA announcement.

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