FDA Recommends Naloxone, Opioid Prescribing Rates Drop

Health care professionals should consider prescribing naloxone to patients taking prescribed opioids who are at increased risk of opioid overdose, the FDA said in a recent Drug Safety Communication.¹

The FDA strongly encouraged that the recommendations be added to the prescribing information for opioid pain medicines and medicines to treat opioid use disorder (OUD), including buprenorphine, methadone and naltrexone.

Naloxone, an opioid reversal medication, should also be considered for patients taking benzodiazepines or other medications that have the potential to depress the central nervous system. The FDA further recommended that a patient with prescription opioids keep naloxone on hand should other household members— including children — or other close contacts accidentally ingest opioids or overdose, the agency said.

“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” said FDA Commissioner Stephen M. Hahn, MD, in a news release.² “Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose.”

The news followed the heels of a recent American Medical Association (AMA) Opioid Task Force report, which found a dramatic drop in the use of prescription opioids, but a significant increase in fatalities involving illicit opioids, stimulants, heroin, and cocaine.³

Deaths involving prescription opioids decreased from 12,269 at the beginning of 2015 to 11,904 at the end of 2019, the AMA reported, citing CDC data.3 During the same time period, deaths involving illicitly manufactured fentanyl and fentanyl analogs increased spiked from 5766 to 36,509.

“The nation needs to confront the fact that the nation’s drug overdose epidemic is now being driven predominantly by highly potent illicit fentanyl, heroin, methamphetamine, and cocaine, although mortality involving prescription opioids remains a top concern,” said AMA Opioid Task Force chair Patrice A. Harris, MD, immediate past president of AMA, in a news release.⁴

The FDA Drug Safety Communication suggested that even if a patient has not been prescribed an opioid analgesic or medicine for OUD but are at increased risk for opioid overdose, a prescription for naloxone should be considered. Health care professionals should also educate patients on methods for recognizing respiratory depression and how to administer naloxone, as well as the importance of seeking emergency medical help immediately should an overdose occur.¹

“If it weren’t for naloxone, there likely would be 10s of thousands additional deaths. It is past time for policymakers, health insurers, pharmacy chains, and pharmacy benefit managers to remove barriers to evidence-based care for patients with pain and those with a substance use disorder,” Harris said.

References:

1. FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. FDA; July 23, 2020. Accessed July 27, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain
2. FDA requiring labeling changes for opioid pain medicines, opioid use disorder medicinesregarding naloxone. News release. FDA; July 23, 2020. Accessed July 27, 2020. https://www.fda.gov/news-events/press-announcements/fda-requiring-labeling-changes-opioid-pain-medicines-opioid-use-disorder-medicines-regarding
3. Opioid Task Force Report 2020 Progress Report: Physicians’ Progress Toward Ending the Nation’s Drug Overdose and Death Epidemic. AMA; July 20, 2020. Accessed July 27, 2020. https://www.ama-assn.org/system/files/2020-07/opioid-task-force-progress-report.pdf
4. AMA report shows evolving, deadlier ovoid overdose epidemic. AMA; July 20, 2020. Accessed July 27, 2020. https://www.ama-assn.org/press-center/press-releases/ama-report-shows-evolving-deadlier-overdose-epidemic