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  1. Drug Safety and Availability

FDA announces new safety label changes for opioid pain medicines

The FDA is requiring several updates to the prescribing information for immediate-release (IR) and extended-release/long-acting (ER/LA) opioid analgesics. The updates also include a new warning about opioid-induced hyperalgesia (OIH) which is a condition where opioids cause an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia).

Opioid pain medicines are an important treatment option in appropriate situations when used as prescribed; however, they also have serious risks. Although the number of dispensed prescriptions for opioid pain medicines has substantially decreased, data suggests that patients who use opioids for pain relief after surgery often have leftover tablets, which can pose a risk for nonmedical use, accidental exposure, addiction, and overdose. We also know that for a number of disorders that can cause chronic pain, non-opioid medications and other treatments can provide effective pain relief without the risks associated with opioid medications. These safety labeling changes (SLCs) are intended to provide clarity on appropriate patient populations for opioid treatment, appropriate dosage and administration, and updated information on the risks associated with opioid use.

“The FDA understands the important role opioid pain medicines have as a treatment option to manage pain; however, it is critically important that opioids are appropriately prescribed and patients are fully educated to reduce the risks of nonmedical use and overdose,” said Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research. “These labeling updates are an outcome of our comprehensive work to review the labeling of opioid analgesics and make modifications that will support safer use of these medicines, as well as shared decision-making between health care providers and patients regarding balanced pain management.”

The required safety labeling changes, listed in the Drug Safety Communication , include stating:

  • the risk of overdose increases as the dosage increases for all opioid pain medicines;
  • IR opioids should not be used for an extended period of time unless a patient’s pain remains severe enough to require them and alternative treatment options continue to be inadequate;
  • many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; and
  • it is recommended to reserve ER/LA opioid pain medicines for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.

The updates also include a warning about OIH for both IR and ER/LA opioid pain medicines, including information on differentiating OIH symptoms from those of opioid tolerance and withdrawal.

This action is just one facet of the FDA’s progress towards implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. We remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

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