Story at a glance

  • New FDA requirements mandate that opioid labels are updated to recommend drugs to counter overdoses alongside prescriptions.
  • This comes as the coronavirus pandemic ravages health care resources.

The U.S. Food and Drug Administration (FDA) issued new recommendations on Thursday, advising doctors to discuss the availability of naloxone, a drug used to reverse drug overdoses, commonly known as Narcan. 

The FDA also now requires labeling on opioid painkillers describing treatment for opioid use disorder (OUD) or addiction be updated to recommend the joint prescription of naloxone along with opioid treatments. 

Opioid overdoses have plagued the U.S. as health care providers began frequently prescribing opioids as a common pain relief, with the assurance from manufacturing pharmaceutical companies that they were not addictive. This falsehood led to mass dependence on opioids, resulting in an increase in overdoses as well as the surge of illegal drug use, such as heroin and fentanyl. 

By 2017, more than 47,000 Americans died from opioid overdoses, leading the U.S. Centers of Disease Control and Prevention (CDC) to classify it as an epidemic. 

Even as COVID-19 grips U.S. health care systems, opioid deaths are still a massive problem, with some reporting the coronavirus pandemic is exacerbating the opioid epidemic. 

In light of this continuing public health crisis, the FDA is now instructing health care professionals to consider prescribing naloxone alongside opioid prescriptions, such as OxyContin or Percocet, especially if the patient lives in a household with children or are at an increased risk of an opioid overdose. 

“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” FDA Commissioner Stephen M. Hahn said in a prepared statement. “We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put an important medicine for combatting [sic] opioid overdose and death in the hands of those who need it most — those at increased risk of opioid overdose and their friends and family.”

The new labeling requirements and recommendations are meant to help prevent further overdoses and target patients who are using other medicines to depress the central nervous system, like benzodiazepines, who have a history of OUD or have experienced a previous overdose. 

It also applies to patients taking medicines for an OUD, such as methadone and buprenorphine, two drugs used to treat opioid addictions. 

Naloxone as Narcan is available as a nasal spray, an injectable and an auto-injector. It works by blocking the receptors’ opioids target in the brain, preventing the drug from taking effect. It is available through community distribution programs, and has seen success in civilian usage. 

Adam Kartman, the founder and medical director of Cascade Medical Advantage in Bellingham, Wash., touted the beneficial results of Narcan in civilian hands. 

“From various documented reports, we know more than 3,000 people with overdoses have seen their lives saved by the administration of Narcan (medical name Naloxone) since the passage of what’s known as the Good Samaritan Law in 2010,” Kartman told The Bellingham Herald. “This law allows citizens (such a family member) and law enforcement officers to administer Narcan to reverse the effects of an overdose.”

Under Good Samaritan laws, present in every state and Washington, D.C., individuals helping or reporting drug overdoses are eligible for certain legal protections to encourage people to seek emergency medical assistance. 

Published on Jul 24, 2020