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  1. FDA Drug Safety Podcasts

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder

FDA Drug Safety Podcast

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. On July 23, 2020, FDA announced the following recommendations about the opioid reversal medicine, naloxone, to reduce the risk of death from opioid overdose.

For all patients who are prescribed opioid pain relievers, health care professionals should discuss the availability of naloxone (brand names Narcan, Evzio), 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 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.

Increased access to naloxone may help save lives by preventing opioid overdose deaths. We are requiring the manufacturers of all opioids, and medicines to treat OUD, to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioids or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.

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

Side effects involving naloxone should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov and follow us on Twitter @FDA_Drug_Info.

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