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July 24, 2020

FDA requires opioid labels to recommend overdose-reversing Narcan

Policy applies to painkillers and addiction medications

Opioids Naloxone
FDA naloxone opioid Thom Carroll/for PhillyVoice

Drug manufacturers must now include information about Narcan on the labels of opioid painkillers. Narcan, shown above, can reverse opioid overdoses.

Opioid painkillers must now include information about naloxone, a fast-acting medication used to reverse opioid overdoses on their labels.

The U.S. Food and Drug Administration is requiring labels to recommend that physicians consider prescribing naloxone, also known by its brand name Narcan, when prescribing opioid painkillers. Health care providers are urged to discuss naloxone with patients starting and renewing treatment.

The policy also applies to medications used to treat opioid addiction, including methadone, buprenorphine and naltrexone. 

"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," FDA Commissioner Dr. Stephen M. Hahn said.

The FDA recommends doctors consider prescribing naloxone to patients at high risk of overdose. This includes patients who are also taking benzodiazepines, those with a history of opioid use disorder and those who have previously overdosed on opioids. Doctors also should consider prescribing naloxone to patients with household members at risk of accidental ingestion or overdose. 

Naloxone can be administered by anyone with or without medical training, according to the FDA. The medication can significantly reduce the effects of opioid overdose after being administered. It typically works within minutes. 

Fatal drug overdoses hit a record high last year, according to a recent report by the Centers of Disease Control and Prevention. There were 70,980 overdose deaths in 2019 — a 4.6% increase from the previous year. This nearly reversed the progress that had been made in 2018, which saw a 4.8% decline from 2017. 

Naloxone can be dispensed without a prescription in Pennsylvania. Insurance coverage may vary based on the form of naloxone being purchased and a person's insurance plan. 

Prevention Point Philadelphia offers naloxone to individuals without insurance. The city also offers virtual training for using naloxone. Visit the city's website for more information. 

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