FDA Updates Safety Labeling and Prescribing Information for Opioid Pain Meds

The FDA is requiring new warnings in the prescribing information for immediate-release and extended-release/long-acting opioid analgesics to address the risks of nonmedical use and overdose.

The updates include a new warning about opioid-induced hyperalgesia, a condition where opioids cause an increase in pain or an increased sensitivity to pain.

The agency added the following safety labeling changes:

• The risk of overdose increases as the dosage increases for all opioid pain medicines; 
• Immediate-release opioids should not be used for an extended period of time unless a patient’s pain remains severe enough to require them and alternative treatment options continue to be inadequate;
• Many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; and 
• Reserve extended-release/long-acting opioid pain medicines 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. 

Another update in the boxed warning will emphasize the risk of life-threatening respiratory depression, as well as the risks of using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system.

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