FDA Updates Opioid Analgesic Labeling to Help Guide Prescribing Decisions

A warning about opioid-induced hyperalgesia has been added to the prescribing information.

The Food and Drug Administration (FDA) has updated the prescribing information for all opioid analgesics in order to provide additional guidance on how to safely prescribe these medications.

The following labeling updates pertain to both immediate-release and extended-release/long-acting opioid pain medications:

  • A statement on the risk of overdose increasing as the opioid dosage is increased, has been added. According to the new labeling, titration to higher doses should be reserved for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose clearly outweigh the substantial risks.
  • A warning about opioid-induced hyperalgesia (OIH), which occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain, has been added. Symptoms of OIH include increased levels of pain upon opioid dosage increase, decreased levels of pain upon opioid dosage decrease, or allodynia. Cases have been reported with both long-term and short-term use of opioid analgesics. For patients suspected to be experiencing OIH, appropriately decreasing the dose of the opioid analgesic or safely switching to a different opioid moiety may be considered.
  • Information in the Boxed Warning has been reordered to elevate the importance of warnings concerning life-threatening respiratory depression, as well as the risks associated with concomitant use of benzodiazepines or other CNS depressants.

For immediate-release opioid analgesics, the Indications and Usage section has been updated to state that the product should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. According to the FDA, many acute pain conditions require no more than a few days of opioid analgesics.

Additionally, the approved use for extended-release/long-acting opioid analgesics has been updated to recommend use of these drugs be reserved for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

Several other sections of the prescribing information, as well as the patient Medication Guide, have also been updated to better explain the risks associated with opioid analgesics and reduce unnecessary prescribing. A table of key opioid label updates can be found here.

This article originally appeared on MPR


FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. News release. Food and Drug Administration. April 13, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-use.