FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On April 13, 2023, as part of its ongoing efforts to address the nation’s opioid crisis, the FDA is making several updates to the prescribing information of opioid pain medicines to provide additional guidance on the use of these powerful medicines. Opioid pain medicines are an important treatment option when used as prescribed; however, they also have serious risks, including misuse and abuse, addiction, overdose, and death.

Although there has been a substantial overall decrease in the number of dispensed prescriptions for opioid pain medicines, overdose deaths involving prescription opioids have remained steady. Data also suggest that:

• many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine, although the dose and duration of treatment needed to adequately manage pain will vary based on the underlying cause and individual patient factors.
• patients who use opioid pain medicines after surgery often have unused tablets, which may pose a risk of accidental use, misuse and abuse, addiction, and overdose, including by children and teenagers.
• extended-release or long-acting opioid pain medicines have unique risks and should be used only for those with severe and persistent pain.

Based on our review of available data, FDA has also determined that a new warning is needed about opioid-induced hyperalgesia (or OIH), which is when an opioid that is prescribed and taken for pain relief causes an increase in pain (called hyperalgesia) or an increased sensitivity to pain (called allodynia). Although OIH can occur at any opioid dosage, it may occur more often with higher doses and longer-term use. This condition can be difficult to recognize and may result in increased opioid dosages that could worsen symptoms and increase the risk of respiratory depression.

We are requiring several updates to the prescribing information for both immediate-release and extended-release or long-acting opioid pain medicines. This includes stating for all opioid pain that the risk of overdose increases as the dose increases. The updates to immediate-release opioids state these products 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. This may include pain occurring with a number of surgical conditions or musculoskeletal injuries. We are also updating the approved use for extended-release or long-acting 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.

In addition, we are adding a new warning about OIH for both immediate-release and extended-release or long-acting opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.

Information in the Boxed Warning, FDA’s most prominent warning, for all immediate-release and extended release or long-acting 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. 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. We are also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

These changes to the prescribing information are designed to inform about appropriate prescribing of opioid pain medicines while also recognizing that they remain an important treatment option in appropriate situations and that undertreatment of pain (including abrupt discontinuations and forced tapering) carries its own risks, including other morbidities and even the risk of illicit substance use for self-treatment. These changes are designed to provide essential information that prescribers need to prescribe opioid pain medicines appropriately, but the prescribing information itself cannot substitute for individual clinical judgment and talking to patients about their pain control.

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.

For all patients prescribed opioid pain medicines, discuss the availability of naloxone, and consider prescribing it to those at increased risk of overdose. This may include patients who are also using benzodiazepines or other medicines that depress the central nervous system, with a history of opioid use disorder, or have experienced a previous opioid overdose. Health care professionals should also consider prescribing naloxone if the patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid 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 are distinct from opioid tolerance and withdrawal and 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. Advise patients about the risk of OIH and tell them to never increase the opioid dosage without first consulting a health care professional, because this could worsen the pain and increase the risk of respiratory depression.

Side effects involving opioid pain medicines and other medicines should be reported to FDA’s MedWatch reporting program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at Drug Safety Communications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on Twitter @FDA_Drug_Info. Thank you for listening.

Related Information

• FDA Drug Safety Communication: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
• FDA Drug Safety Podcast: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use