FDA Mandates New Warnings for Opioid and Benzodiazepines
Posted on September 20, 2016 by Rita Wilson
In a statement released on September 1, 2016 (FDA Black Box Warning), the Food and Drug Administration (FDA) announced that “after an extensive review of the latest scientific evidence, it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.”
Benzodiazepine medications are most commonly prescribed to treat anxiety and mood disorders, such as depression and insomnia. The drugs also are used to treat seizures. According to the FDA, the number of individuals who were prescribed both opioids and benzodiazepines grew by 41 percent, or 2.5 million, between 2002 and 2014.
States submitted a petition to FDA calling for the agency to add black-box warnings about the potentially fatal combination of opioid painkillers and benzodiazepines to the drugs. The officials said prescription opioids and benzodiazepines often are used together, and data show that almost one in three unintentional overdose deaths from prescription opioids also involved benzodiazepines.
What drugs are impacted?
The agency is requiring that black box warnings, the strongest available, be added to nearly 400 products (of which more than 200 are opioid painkillers) alerting doctors and patients that combining opioids and benzodiazepines can cause extreme sleepiness, slowed breathing, coma, and death.
The FDA is warning patients and their caregivers about the serious risks of taking opioids along with benzodiazepines or other central nervous system (CNS) depressant medicines, including alcohol. Serious risks include unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, coma, and death. These risks result because both opioids and benzodiazepines impact the CNS, which controls most of the functions of the brain and body.
The bigger picture
The agency said the move is one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management. For those who may not know what’s in play or want more information about the national effort, go to TurnTheTideRx.Org to access the U.S. Surgeon General’s plans to curb the epidemic.
In responding to the announcement, FDA commissioner Robert Califf noted, “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” He further added, “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines … together outweigh these serious risks.”
What does this mean to you?
In dealing with workers’ compensation claims for Class I and Class II Medicare beneficiaries, the combination of opioid pain killers and benzodiazepines is a common occurrence. When we see it, we immediately notify the claims handler that this is a dangerous combination and certainly not intended for long term use. For the elderly, drug combinations such as this are even more dangerous as their effects are exacerbated due to the rate at which they metabolize in an elderly person. For those who may not be familiar, there is an excellent resource (2015 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults) that focuses on commonly used drugs and the risks and potential dangers when prescribed to the elderly. According to the guide,
“Older adults have increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents; in general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle crashes in older adults and should be avoided”.
One of many pieces of the opioid puzzle
As stated within the “TurnTheTideRx” campaign literature, it is truly “All hands on deck” if we hope to change the course of the opioid epidemic. It will take patient, family members, friends, and in the case of workers’ compensation claims, claims handlers, nurse case managers, employers, carriers and even MSP compliance providers to help change prescribing habits. While legislative, regulatory and compliance entities can assist by setting policy, it is the physician who writes the first script. When I see that one of the largest emergency rooms in the country (One of Nation’s Largest ERs Kicks the Opioid Habit) can function without writing opioids as first line pain management for acute pain, I am convinced that a change is possible if we can engage our physicians.
We are but one piece of this very complicated puzzle, and “Big Pharma” has deep pockets. Through education of all stakeholders, advocacy to those in positions of power and influence, and our respective collaborative efforts to optimize claims and treatment, we can make a difference in the lives of our patients.
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