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.