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FDA plans to update opioid labels to include pain side effect


The U.S. Food and Drug Administration on Thursday announced updates to the prescribing information for opioid pain medicines, including new warnings on how long-term use can lead to more pain.

The FDA says data shows that patients on the drug are at risk for opioid-induced hyperalgesia, which is when an opioid is prescribed and taken for pain relief causes an increase in pain or sensitivity to pain, or allodynia, and that studies warrant updates to warning labels.

Although hyperalgesia can occur at any opioid dosage, the FDA says it may occur more often with higher doses and longer-term use and that the condition “can be difficult to recognize and may result in increased opioid dosages that could worsen symptoms and increase the risk of respiratory depression.”

The FDA also plans to update labels to state that the risk of overdose increases as the dose increases; that immediate-release opioids 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 related to surgery or musculoskeletal injuries, the FDA said.

The administration is also updating the approved use for extended release/long-acting opioid pain medicines to recommend they be reserved for severe and persistent pain that requires an extended treatment period.