WASHINGTON — The Food and Drug Administration announced Thursday that it would require drug manufacturers to include information about naloxone, the overdose-reversal medication, on the labels of opioid painkillers.
The move comes just weeks after the federal government released new data showing that U.S. drug overdose deaths reached an all-time high in 2019, surpassing the previous peak recorded two years earlier. More recently, the Covid-19 pandemic has led to another increase in overdose deaths as the unemployment rate has skyrocketed and Americans have lost access to health insurance and to many in-person health services like addiction clinics or syringe exchanges.
Naloxone, often referred to by the brand name Narcan, has been used in the U.S. to reverse opioid overdoses since 1971. While it’s often prescribed in an injectable form, it’s also commonly sold as a nasal spray or a mechanized auto-injector, which make the medication easier for people without medical training to deliver.
“Today’s action 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,” Stephen Hahn, the FDA commissioner, said in a statement.
The FDA’s announcement is the latest step in a nationwide effort to distribute naloxone more widely, both to people who use drugs and people likely to witness opioid overdoses.
The Department of Health and Human Services recommended in 2018 that physicians prescribe naloxone alongside opioids to patients at high risk for overdose, like those on high opioid doses or those who take the pain drugs alongside benzodiazepines, a class of medications used to treat anxiety and other health conditions.
In recent years commercial health insurers and local governments have also moved to make naloxone more widely available, including covering the medication at no cost and issuing “standing orders” so that any individual can purchase naloxone at a pharmacy, even without a prescription.
The FDA also said it would require similar labels for the three approved drugs used to treat opioid addiction: methadone, buprenorphine, and naltrexone.
While the move is likely to result in increased awareness and use of naloxone among patients who use prescription opioids for pain, it’s unclear whether it will help reduce overdose deaths for people who use illicit opioids like heroin.
Fentanyl, the ultra-powerful synthetic opioid that illicit drug manufacturers often include in illegally manufactured pills or in heroin itself, is also a major driver of drug overdose deaths.