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Dr Marie Sartain
/ Categories: APhA News

FDA gives all pain meds new safety warnings

After assessing all the available data, FDA said in a new Drug Safety Communication that it is making revisions to prescribing information for opioid analgesics to encourage safe use.

The prescribing information and labeling for extended-release or long-acting (EX/LA) and immediate-release (IR) opioid analgesics will include a warning about opioid-induced hyperalgesia (OIH), or heightened sensitivity to pain. This includes differences between symptoms of OIH and opioid tolerance and withdrawal.

The prescribing information and labeling will also warn that overdose risk increases with higher doses for all opioids. In addition, FDA will revise its approved use for EX/LA opioids “to recommend they be reversed 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.”

Furthermore, the boxed warning label for all opioid analgesics will cite the risks of respiratory depression along with risks linked to the use of opioid analgesics with benzodiazepines or other medicines that can depress the central nervous system.

FDA advised health care providers to discuss the effect of a patient’s pain on their quality of life while also identifying possible causes of pain. If a patient’s pain is more severe and the use of alternative treatment options is insufficient, health care professionals may “prescribe the lowest effective dose of an IR opioid for the shortest duration of time to reduce the risks associated with these products,” FDA said.

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