July 23, 2020

The U.S. FDA is requiring all drug manufacturers of opioid pain relievers and medicines used to treat opioid use disorder (OUD) to add new recommendations about naloxone, a medication used for emergency treatment of opioid overdose, to their products’ prescribing information.

The requirement follows the recommendation of the Anesthetic and Analgesic Drug Products Committee and the Drug Safety and Risk Management Advisory Committee, which determined that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their healthcare professional about the availability of naloxone.

The FDA recommends that healthcare professionals take the following steps:

  • Discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or a 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.
  • Consider prescribing naloxone when a patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
  • Even if 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—a life-threatening sign of opioid overdose—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.

The full safety alert regarding naloxone recommendations can be viewed on the FDA’s website.

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