The FDA has made several updates to its opioid prescribing information, including new warnings about the possibility for increased pain, which can lead to dangerous adverse reactions such as respiratory depression.
The updates, announced in a Tuesday drug safety communication, include warnings about the risk of opioid-induced hyperalgesia (OIH) for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medications. OIH can occur when patients experience an increased sensitivity to pain, which may prompt higher dosages. This can in turn lead to respiratory depression, a potentially deadly condition, the FDA said. OIH typically occurs when opioids are prescribed for pain relief at relatively high doses and for long-term use.
Opioids should generally not be used for an extended period unless required for ongoing, severe pain in the absence of alternative treatments, the FDA added. Many outpatients with acute pain conditions — such as pain occurring with certain surgical procedures or musculoskeletal injuries — require no more than a few days of medication, with the final determination based on individual patient factors, it noted.
ER/LA opioid pain medications specifically should be reserved for severe and persistent pain that requires an extended treatment with daily medicine, and when there is no alternative treatment option, the agency added.
Boxed warnings will be updated, reminding clinicians and patients about the risks for OIH and related adverse outcomes. Prescribers and users will also be cautioned about using opioid pain medicines with benzodiazepines and other medicines that may depress the central nervous system.
Additional information for clinicians can be found in the FDA release and in the updated prescribing information for individual drugs on the agency’s website.
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