New Recommendations for Naloxone
[7/23/2020] To reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration has made the following recommendations about the opioid reversal medicine, naloxone:
For all patients who are prescribed opioid pain relievers, health care professionals should discuss the availability of naloxone, and consider prescribing it to patients who are at increased risk of opioid overdose, such as patients who are also using benzodiazepines or other medicines that depress the central nervous system, who have a history of opioid use disorder (OUD), or who have experienced a previous opioid overdose. Health care professionals should also consider prescribing naloxone if the patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
For all patients who are prescribed medicines to treat OUD, health care professionals should discuss the availability of naloxone and strongly consider prescribing it. For methadone and buprenorphine-containing products, health care professionals should also consider prescribing naloxone if the patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
For other patients at increased risk of opioid overdose, health care professionals should consider prescribing naloxone, even if the patient is not receiving a prescription for an opioid pain reliever or medicine to treat OUD. This may include people with a current or past diagnosis of OUD or who have experienced a previous opioid overdose.
- FDA News Release: FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone
- Drug Safety Communication: FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
- Example safety labeling change notification letter for opioid analgesics (PDF - 124 KB)
- Example safety labeling change notification letter for medicines used to treat opioid use disorder (PDF - 121 KB)
- FDA Response to Citizen Petition: Letter from FDA to Lachman Consultant Services, Inc