Drug Safety Alerts

Naloxone MedWatch

7/23/2020

On July 23, 2020, The United States Food and Drug Administration (FDA) published a drug safety communication announcing that they are requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information to encourage all health care professionals to discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.

The FDA has provided the following recommendations for healthcare providers:

• Routinely discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD. Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose. Patients receiving medicines to treat OUD have a lower risk of opioid overdose than those with OUD who are not being treated; however, they are still at risk of relapse and opioid overdose. Also, consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

• Additionally, even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.

• Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone. Inform them about their options for obtaining naloxone as permitted by their individual state dispensing and prescribing requirements or guidelines for naloxone. Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.

• Discuss naloxone with all patients and/or their caregivers when prescribing opioid analgesics or medicines to treat opioid use disorder (OUD). Assess the potential need for patient or home access to naloxone, both when initiating and renewing treatment with opioid analgesics and medicines to treat OUD.

• Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose, such as those who are also using benzodiazepines or other CNS depressants, who have a history of OUD, or who have experienced a previous opioid overdose. Additionally, consider prescribing naloxone to patients who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

• The existence of a risk factor for opioid overdose should not prevent the proper management of pain in any given patient. Patients at increased risk of overdose may be prescribed opioid analgesics, if other options for pain management are inadequate and opioid treatment is indicated. However, use in such patients necessitates intensive counseling about the risks and proper use of these products, along with intensive monitoring.

• Consider prescribing naloxone to other patients at increased risk of opioid overdose, even if they are not receiving a prescription for an opioid analgesic or medicine to treat OUD. These include people with a current or past diagnosis of OUD or who have experienced a previous opioid overdose. Patients receiving medicines to treat OUD have a lower risk of overdose than those not being treated, however they are still at risk of relapse and overdose.

• Familiarize yourself with the options for patients to obtain naloxone as permitted by your individual state dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) for naloxone. Inform patients and caregivers of these options.

• Educate patients and caregivers that taking an opioid other than how it is prescribed or with alcohol or certain other medicines or drugs could increase the risk of overdose and how to recognize the signs and symptoms of an overdose.

• Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.

• If naloxone is prescribed, educate patients and caregivers on the proper use of naloxone in the event of an overdose. Advise them to tell their family and friends that they have it, and to keep it in a place where their family and friends can easily access it in an emergency.

• Encourage patients and caregivers to read the Patient Information leaflet or other educational material and Instructions for Use that come with naloxone before an opioid emergency happens.

• Educate patients and caregivers on proper storage and disposal of opioids.

• To help FDA track safety issues with medicines, report adverse events involving naloxone, opioids, or other medicines to the FDA MedWatch program.

For more information about this issue, health care providers may call the FDA consumer inquiry line toll-free at 1‑855‑543-DRUG (1‑855-543-3785) or email druginfo@fda.hhs.gov. You can also visit https://www.fda.gov.