Manufacturers are being required by the FDA to add recommendations about naloxone to prescribing information for all opioids, including buprenorphine and methadone which are used to treat opioid use disorder (OUD). This measure is to ensure prescribers have a discussion with the patient about, and assess appropriateness of, naloxone when prescribing these medications in the outpatient setting. Patients at highest risk for opioid overdose include those with a history of opioid use disorder, previous opioid overdose, and concomitant use of benzodiazepines. The FDA also recommends assessing the appropriateness of naloxone when NOT prescribing these medications if the patient is at risk for opioid overdose. They hope to increase awareness of the availability of naloxone in response to the current opioid public health crisis. Patient medication guides are also being updated.
Opioids are medications used to treat pain and OUD. Risks associated with these medications include abuse and addiction, overdose (eg slowed, shallow, or difficult breathing; inability to wake from sleep or respond; severe somnolence), and death. Naloxone is a short-acting opioid reversal agent that can prevent death by reversing opioid effects in the setting of an overdose.
Patients and health care professionals can report side effects or adverse drug events related to the use of these products to the FDA by submitting the report online, downloading the form or calling 1-800-332-1088.
Additional information is available at the following links: