MedWatch Update on Naloxone


In a Safety Communication on July 23, 2020, the FDA alerted prescribers, pharmacies and patients of a new requirement for opioid drugs. It is directing drug companies that make opioids for pain relief and for use in treating opioid use disorder to add information on the labels about the use of naloxone. As emergency treatment for opioid overdoses, naloxone blocks breathing problems that can cause death from overdoses. Several doses may be needed to control an overdose, but naloxone is not a substitute for emergency medical help. Even if it is used to reverse an overdose, 911 should be called and medical attention given to the patient. The FDA suggests that health professionals who prescribe opioids discuss naloxone with patients and provide prescriptions for those who might be at risk for overdoses. Some states allow pharmacies to dispense it without a prescription. Patients and their caregivers should be trained in how and when to use naloxone, and patients should carry it with them. Please see the FDA’s notice for more information.