In April, the U.S. Food & Drug Administration (FDA) announced updates to the prescribing information for immediate-release (IR) and extended-release/long-acting (ER/LA) opioid medications. The update included a reminder: All opioids used for pain management are associated with an increased risk of overdose when the dose is increased.
The FDA changes include the following:
- For ER/LA products: The FDA recommends these agents be reserved for severe and persistent pain that requires daily, extended treatment when alternate treatment options prove inadequate; and
- For IR products: These agents should not be used for an extended period unless the pain remains severe enough to require them and alternative treatments continue to be inadequate. The FDA notes that many acute pain conditions treated in outpatient settings, such as pain from surgical conditions or musculoskeletal injuries, require no more than a few days of IR opioid treatment.
Label Updates
The FDA added a new warning about opioid-induced hyperalgesia (OIH) to the labels for IR and ER/LA opioid products. This warning includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal. OIH occurs when opioids cause an increase in pain or increased sensitivity to pain that is different from opioid tolerance or withdrawal and can be difficult to recognize.
Additionally, the FDA will update and reorder the Boxed Warnings for all IR and ER/LA opioid products, boosting the importance of warnings about life-threatening respiratory depression, and the risks of concomitant opioid and benzodiazepine or other medication use, which can cause central nervous system depression.
Other required label changes include changes to the Indications and Usage, Dosage and Administration, and Warnings/Precautions sections. The FDA is also requiring updates to existing patient medication guides to help educate patients and caregivers about these risks.
Pain Management
When treating patients for pain, healthcare professionals should:
- Use the lowest effective dose of an IR opioid product for the shortest amount of time;
- Reserve ER/LA opioid products for severe and continuous pain that needs extended treatment with daily opioids when alternate treatment options are inadequate;
- Due to the risk of overdose, ensure naloxone is available for all patients who are prescribed opioids;2 and
- Be aware of the symptoms of OIH, which are difficult to recognize and different from opioid tolerance and withdrawal.
If a patient is thought to be experiencing OIH, healthcare professionals should carefully consider a dose decrease or safely substitute a different opioid, if tolerated. Patients should be educated about the risk of OIH and instructed to never increase their opioid dose without first consulting a healthcare professional.
OTC Naloxone
In late March, the FDA approved the use of over the counter (OTC), nonprescription naloxone hydrochloride (Narcan) as a 4 mg nasal spray.2 Naloxone is a life-saving medication that has the potential to reverse an opioid overdose.
This treatment is the first FDA-approved naloxone product that will not require a prescription. It will be sold directly to consumers in pharmacies, convenience stores, grocery stores and other locations. It will also be sold online.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Drug safety communication: All opioid pain medicines—FDA updates prescribing information to provide additional guidance for safe use. U.S. Food & Drug Administration. 2023 Apr 13.
- News release: FDA approves first over-the-counter naloxone nasal spray. U.S. Food & Drug Administration. 2023 Mar 29.
