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Opioid pain meds get new safety warning

From MedPage Today

All Opioid Pain Meds to Get New Safety Warnings, FDA Says

— Updated labeling to include warning about opioid-induced hyperalgesia

The FDA is making several updates to the prescribing information for opioid pain medications to provide guidance on safe use, according to a Drug Safety Communicationopens in a new tab or window, including a new warning that they can increase sensitivity to pain.

African American man with glasses looking at the labels of two prescription bottles

Changes to the prescribing information and labeling for immediate-release (IR) and extended-release or long-acting (EX/LA) opioids will be made to more clearly state that overdose risk increases with higher doses for all opioids.

In addition, labeling for IR opioids will state that they should not be used for extended periods, unless alternative treatment options are considered inadequate. The agency will also update its approved use for EX/LA opioids “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.”

After a review of the available data, the FDA decided that a new warning about opioid-induced hyperalgesia (OIH), or an increased sensitivity to pain, was needed for all opioid prescriptions, and will include information describing the difference between symptoms of OIH and opioid tolerance and withdrawal.U.S. Food and Drug Administration logo

This will also include an update to the boxed warning label for all opioid medications, which will highlight the risks of respiratory depression, as well as those associated with use of opioids with benzodiazepines or other medicines that can depress the central nervous system.

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