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The FDA recently announced a new label requirement for prescription opioids and medications that treat opioid use disorder (OUD).
To anticipate potential overdose risks and patients with a higher likelihood of overdosing, the government agency recommends doctors and other healthcare professionals discuss the availability and usage of naloxone – a growing overdose reversal treatment – when prescribing.
Naloxone is the only drug approved by the FDA for addressing and reversing the effects of an opioid-related overdose. Based on figures from the Centers for Disease Control and Prevention (CDC), its usage for this purpose has grown since 2017, although the drug itself has been around since the 1970s.
“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” FDA Commissioner Stephen M. Hahn, MD, said in a press statement. “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.”
Uptick in Overdoses
The FDA’s latest requirement to attempt to control the opioid crisis follows recommendations from the Department of Health and Human Services in 2018.
Two years ago, the agency suggested that doctors prescribe naloxone along with opioids for patients who have a higher likelihood of overdosing. At the time, their recommendations targeted individuals prescribed prescription painkillers with benzodiazepines and those with a history of opioid-related overdoses.
The FDA’s effort also coincides with a spike in opioid-related overdoses and fatalities. Attributed to a sharp drop in social services and sudden unemployment for many, along with increased availability of synthetic opioids in the US, opioid-related fatalities peaked in 2019 and have remained steady during the COVID-19 pandemic.
Additionally, a higher number of street drugs are being cut with fentanyl and other harmful substances. Simultaneously, services like support groups, methadone clinics and needle exchanges closed at the start of the Coronavirus pandemic. This trend left many people recovering from opioid addition without resources and may have contributed to some relapses.
Changes Being Made
In a Drug Safety Communication, the FDA outlined its plan to ultimately increase access to naloxone and reduce the number of opioid-related deaths. As its big-picture initiative, the FDA is requiring all drug manufacturers for opioids and OUD medications like buprenorphine, methadone and naltrexone to add recommendations about treating overdoses with naloxone to the prescribing information.
Building off this, healthcare professionals must discuss where and how to get naloxone and assess each patient’s specific needs for a naloxone prescription. This pattern should repeat whenever the doctor is initially prescribing opioids and for any medication renewals.
Patients identified by the FDA as having the greatest risk of overdose – and thus the most significant need to access naloxone – include:
- Individuals currently living with or with a previous history of OUD.
- Individuals who have already experienced at least one overdose incident.
- Patients who take benzodiazepines or another medication that depresses the central nervous system in addition to a prescription opioid.
- Patients with children or other household members who could accidentally ingest a prescription opioid or opioid analgesic.
The FDA has further recommended that doctors not only discuss the availability of naloxone but also issue a prescription for it. To date, certain pharmacies and community programs offer the overdose-reversal drug over the counter, but others still require a prescription, limiting access to this life-saving medication in certain regions. On this last point, doctors should cover where, with state-specific directions, a patient and their family members can find naloxone.
In addition, the FDA has further stated that doctors and other healthcare professionals go over how to recognize respiratory depression – a precursor to or immediate sign of an overdose – and the proper way to administer naloxone. All healthcare professionals should further stress the need to call 911 or get emergency medical help after administering the drug.
Not the First Label Change
The FDA’s latest update comes just over a year after it touched on the risks of suddenly discontinuing opioids when patients are dependent. This statement clarified and expanded upon the CDC’s 2016 recommendations for reducing and limiting opioid prescriptions.
Suddenly discontinuing opioids after a patient has developed a dependency or addiction often leads to withdrawal, intensified pain, psychological symptoms and increased risk of suicide. This shift also pushes many to seek out illicit opioids like heroin or street-grade fentanyl.
This change involved updating the prescribing information with additional guidance for safely decreasing a patient’s opioid prescription, using specific OUD medications and addressing any psychological concerns that could result.
What is Naloxone?
Often called by its brand name “Narcan”, naloxone was introduced in the US as an overdose reversal drug in 1971. For years it was injected, but for ease of use by those without medical training, it’s also available as an auto-injector and nasal spray.
Naloxone does not address one specific type of opioid overdose. Rather, it can be administered to reverse the process if an individual takes the drug on its own, with alcohol or in conjunction with another controlled substance, like cocaine. Once dispensed, the medication assists with reversing the respiratory depression and breathing problems brought on by the overdose.
However, its effects can be temporary and, for certain opioids like fentanyl, more than one dose of naloxone may be needed. In turn, naloxone is never enough by itself and emergency assistance is essential to help the victim.
While the number of prescriptions has grown, the CDC points out that only one naloxone prescription is administered for every 70 opioid overdoses. Rural areas are less likely to dispense the drugs than urban regions and, for areas that require a prescription, a copay may be required to access the drug.
Drug companies who spread inaccurate information and convinced doctors to issue more prescriptions helped spur the opioid epidemic. Now, more than 20 years later, many Americans are paying the price.
