The FDA 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. Additional, specific updates will also be made respectively to immediate-release opioids and extended-release/long-acting opioids.
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