Home » FDA Updates Safety Labeling and Prescribing Information for Opioid Pain Meds
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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