April 13, 2023 – The FDA is making several updates to prescribing information for opioid pain medications to provide guidance on safe use, according to a Drug Safety Communication … opens in a new tab or window, including a new warning that they can increase sensitivity to pain.
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.”
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