The US Food and Drug Administration on Thursday announced updates to the prescribing information for opioid painkillers, including new warnings about how long-term use can lead to more pain.
The FDA says data shows patients on the drug are at risk for opioid-induced hyperalgesia, which is when an opioid prescribed and taken for pain relief causes an increase in pain or sensitivity to pain, or allodynia, and that studies require updates to warning labels.
Although hyperalgesia can occur at any opioid dose, the FDA states that it may occur more frequently with higher doses and long-term use and that the condition “may be difficult to recognize and may result in increased opioid doses that may worsen symptoms and increase the risk of respiratory depression.”; “
The FDA also plans to update the 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 pain remains severe enough to require them and alternative treatments continue to be inadequate; and that many acute pain conditions treated on an outpatient basis do not require more than a few days of an opioid pain medication. This can include pain related to surgery or musculoskeletal injuries, the FDA said.
The administration is also updating the approved use of extended-release/long-acting opioid pain medications to recommend that they be reserved for severe and persistent pain that requires a longer period of treatment.