FDA Makes Series of Recommendations on Naloxone

In an effort to reduce the risk of death from opioid overdose, the FDA recently made a series of recommendations around naloxone for both healthcare professionals and patients.

In a communication document published in July, FDA wrote that providers should discuss the availability of naloxone and consider prescribing it to patients deemed at increased risk of overdose, such as patients using benzodiazepines, those with a history of opioid use disorder, and those who have previously overdosed.

“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,” FDA wrote.

The administration is also recommending healthcare professionals consider prescribing naloxone to patients at an increased risk of opioid overdose, regardless of whether they currently are receiving a prescription for an opioid pain reliever or are engaging in medication-assisted treatment. The naloxone prescribing recommendation extends to cases in which the patient has household members or other close contacts at risk for accidental ingestion or opioid overdose, as well.

FDA is also requiring drug manufacturers for all opioid painkillers and medicines used to treat OUD to add new recommendations about naloxone to prescribing information. Medication guides, the paper handouts with FDA-approved information that come with many prescription medications to help patients avoid adverse events, will also be updated accordingly, the administration said.