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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

FDA Updates Prescribing Information for all Opioid Pain Medicines to Provide Additional Guidance for Safe Use

The FDA released a Drug Safety Communication on April 13, 2023 1 to provide information on new requirements and updates to the prescribing information for both immediate release (IR) and extended release/long acting (ER/LA) opioid pain medicines. Despite substantial declines in the rates for opioid pain medicine dispensing, prescription opioid medicine-involved overdose deaths have remained relatively steady over time. Key changes include:

  • Prescribing information will contain a statement that with all opioid pain medications the risk of overdose increases as the dose increases.
  • Prescribing information will contain a statement that IR opioids should not be used for an extended period unless the pain remains severe enough to require them and alternative treatments continue to be inadequate, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
  • The FDA is updating the approved use for ER/LA opioid pain medicines to recommend they be reserved 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 FDA is adding a new warning about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. OIH is a condition where opioids cause an increase in pain (called hyperalgesia) or an increased sensitivity to pain (called allodynia) that is distinct from opioid tolerance and withdrawal.
  • Information in the Boxed Warning, FDA’s most prominent warning, for all IR and ER/LA opioid pain medicines 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).
  • Updates to the existing patient Medication Guides to help educate patients and caregivers about the risks of opioid medications.

Recommendations for Healthcare Providers

  • In assessing the severity of pain, discuss with the patient the impact of the pain on their ability to function and their quality of life. Assessment of pain should consider both the cause of pain and individual patient factors.
  • If the patient’s pain is severe enough to require an opioid pain medicine and alternative treatment options are insufficient, prescribe the lowest effective dose of an IR opioid for the shortest duration of time to reduce the risks associated with these products. Many acute pain conditions, such as pain occurring with a number of surgical procedures or musculoskeletal injuries, require no more than a few days of an IR opioid pain medicine.
  • Reserve ER/LA opioid pain medicines only 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. Inform patients of the added risks of using opioid pain medicines with benzodiazepines and other CNS depressants, and educate them on the signs and symptoms of respiratory depression.
  • For all patients prescribed opioid pain medicines, discuss the availability of naloxone, and consider prescribing it to those at increased risk of overdose. In March 2023, FDA approved an inhaled nasal spray version of naloxone to be sold over-the-counter without a prescription.
  • Be aware that the symptoms of OIH can be difficult to recognize. If a patient is suspected to be experiencing OIH, carefully consider an appropriate decrease in dose of the current opioid pain medicine or safely switching them to a different opioid product, if tolerated.

To help FDA track safety issues with medications, please report adverse events to the MedWatch program. Instructions for reporting can be found online at the NPTC Pharmacovigilance website - please enter "IHS" in section G of the form.

1 Food and Drug Administration. (2023, April 13).FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. Link