May 20, 2023

FDA to Update Prescribing Information for All Opioid Pain Medications

The FDA announced they will be requiring several updates to the prescribing information for all opioid pain medications.

All opioid pain medications will note that the risk of overdose increases as the dose increases, as well as a new warning about opioid-induced hyperalgesia (OIH) with information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.

Boxed warnings across all opioids will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).

Other changes are also being required to several sections of the prescribing information, including to the Indications and Usage, Dosage and Administration, and Warnings and Precautions sections. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Labels for immediate-release (IR) opioids will note that opioids should not be used for an extended period of time, unless the pain remains severe enough to require them and alternative treatments continue to be inadequate. Furthermore, label updates will state that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; this may include pain occurring with a number of surgical conditions or musculoskeletal injuries.

The approved use for extended-release (ER) and long-acting (LA) opioids will be modified, reserving these opioids 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.

Several more guidance initiatives were announced, divided into provider and patient recommendations.


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