TOPIC: FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use

AUDIENCE: Patient, Health Care Professional, Pain Management

ISSUE: In May 2025, the FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss two recently completed observational studies examining the risks of misuse, abuse, addiction, and fatal and non-fatal overdose in patients on long-term opioid analgesic (also referred to as opioid pain medicine) therapy. These studies (postmarketing requirements [PMR] 3033-1 and 3033-2) provided new, quantitative data on risks of these serious adverse outcomes in patients prescribed opioid pain medicines long term. After reviewing the study findings and the medical literature, as well as considering the committees’ and public input, FDA has determined that this new information should be included in drug labeling to help health care professionals and patients better understand the benefit-risk profile of opioid pain medicines when prescribed long term and to make more informed decisions. Separately, a prospective, randomized, controlled clinical trial will address a different PMR to examine the risks relative to the efficacy of long-term opioid use.

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BACKGROUND: Opioid pain medicines are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough relief. However, opioid pain medicines also carry serious risks, including misuse and abuse, addiction, overdose, and death.

RECOMMENDATIONS:

Health Care Professionals

• In assessing the severity of pain, discuss with the patient the source of the pain and the impact of the pain on their ability to function and their quality of life.
• 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 immediate-release (IR) opioid pain medicine for the shortest duration of time needed to reduce the risks associated with these products.
• Reserve extended-release/long-acting opioid pain medicines only for severe and persistent pain that cannot be adequately treated with alternative options, including IR opioid pain medicines.
• For all patients prescribed opioid pain medicines, discuss opioid overdose reversal agents, such as naloxone and nalmefene.
• Regularly re-evaluate the benefit-risk profile for any individual taking opioid pain medicines for more than a few days. If you determine opioid pain medicines are indicated, consider an IR opioid pain medicine as an as-needed, first-line treatment.
• Avoid rapidly reducing or abruptly discontinuing opioid pain medicines in patients who may be physically dependent on the medication because such changes have resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Patient or Parent/Caregiver

• Always take your opioid pain medicine exactly as prescribed. Do not take more of the medicine or take it more often than prescribed without first talking to your health care professional. Talk with them if your pain increases, you feel more sensitive to pain, or if you have new pain, especially from touch or other things that are not usually painful such as combing your hair.
• Store your opioid pain medicines securely, out of sight and reach of children and pets, and in a location not accessible by others, including home visitors. Do not share these medicines with anyone else, and immediately dispose of unused or expired opioid pain medicines or take them to a drug take-back site, location, or program. If provided, use the prepaid mail-back envelopes included with the prescription.
• Seek emergency medical help or call 911 immediately if you or someone you are caring for experiences symptoms of respiratory problems, which can be life-threatening. Signs and symptoms include slowed, shallow, or difficult breathing, severe sleepiness, or not being able to respond or wake up.
• Talk to your health care professionals about the benefits of naloxone and nalmefene, which can reverse an opioid overdose, and how to obtain these drugs.
• Be aware that overdose risks are increased with higher opioid pain medicine doses and that the risks of serious harms persist over the course of therapy. Avoid rapidly reducing or abruptly discontinuing opioid pain medicine treatment without consulting a health care professional.

[07/31/2025 - Drug Safety Communication - FDA]

[07/31/2025 - Press Release - FDA]