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FDA Requires Naloxone Discussion to Be Part of Opioid Labeling, Prescribing

August 13, 2020

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Opioid use following otolaryngology surgical procedures has received increased interest, with many studies recommending shorter-term prescriptions for opioids to avoid dependence on the drugs.

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In response to a continuing opioid crisis in the United States, the FDA announced on July 23 that it will require that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that healthcare professionals discuss, as a routine part of prescribing these medicines, the availability of naloxone with patients and caregivers, both when beginning and when renewing treatment.

The required labeling changes recommend that healthcare professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Additionally, the labeling changes recommend that healthcare professionals consider prescribing naloxone to patients who are being prescribed opioid pain medicines and are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose. A naloxone prescription should also be considered for patients with household members or other close contacts, including children, who are at risk for accidental ingestion or opioid overdose.

Filed Under: Online Exclusives Tagged With: FDA, opioids

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