The FDA is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing those medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. The action, announced in a Drug Safety Communication “can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose,” said FDA Commissioner Stephen M. Hahn. The required labeling changes recommend that health care professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Additionally, the labeling changes recommend that health care professionals consider prescribing naloxone to patients being prescribed opioid pain medicines who 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.
The FDA has published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the agency for any eligible investigational drug they provide to eligible patients under the Right to Try Act, which provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments.