The Food and Drug Administration has upgraded its prescribing information and guidelines in light of data on the contribution of prescribed opioid medicines to overall opioid-related morbidity and mortality.
Opioid drugs are potent analgesics prescribed to counter pain that is not responding to other analgesics or treatments. However, these medications are associated with significant safety concerns regarding adverse effects, abuse, addiction, overdosing, and death. Several studies have highlighted the role of prescription opioid medications in the ongoing opioid crisis in the U.S. The data from these suggests:
- Some patients who are prescribed opioids progress to non-medical abuse.
- Overdose leads to death, and significant morbidities such as brain injury or respiratory depression can occur along with societal impacts like addiction, loss of family members, and mental health issues.
- There is continued overprescription of opioids in some acute painful conditions despite the presence of alternative effective non-opioid medications.
Considering this data, the Food and Drug Administration (FDA) published its revised information and guidelines regarding opioid prescription on April 13. This includes updates for both immediate-release (IR) and extended-release (ER) opioid analgesics. A summary of these label updates is as follows:
Boxed Warning: FDA’s most conspicuous warning, this will be updated to improve warnings about life-threatening respiratory depression and risks associated with the concomitant use of opioids and other central nervous system depressants.
Medication Guides: These are being updated to educate patients and their caregivers regarding the associated risks.
Indications and Usage: Extended use of IR opioids and effective alternative analgesics is discouraged.
Dosage and Administration:
- Health professionals are instructed to prescribe the lowest effective dose of opioids for the shortest duration needed for treatment, as the risk of overdose increases with increasing doses.
- Patients should be regularly reassessed for the continued need for opioid medication and signs of abuse and addiction.
- Patients should only use the medicine as prescribed and avoid other medications during the treatment that can cause CNS depression, overdose, and respiratory depression.
- Ensure the availability of naloxone for any possible opioid emergency. Consider prescribing naloxone as a precautionary measure for patients at high risk of overdose.
- New information is being added on opioid-induced hyperalgesia, a condition in which opioids cause an increase in severity and sensitivity to pain. This should be recognized and managed in a timely manner, as it can lead to respiratory depression.
ResearchU.S. Food And Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-use