“Elephant tranquilizer.” “Ultra-potent.” “10,000 times stronger than morphine.” “Chemical weapon.”
This is how some of today’s opioids are referred to as they make their way through the streets and backyards of our country. These extremely potent opioids, such as fentanyl and carfentanil, are taking lives and devastating families across our great nation and particularly in states like Ohio, New Hampshire, and Kentucky.
This means we have to get more naloxone administered as soon as overdose symptoms become apparent, and as a result, the current initial, recommended dose of naloxone has been widely challenged as ineffective against the current and evolving opioid epidemic. Specifically, it is common practice today to immediately provide at least two doses of this lower naloxone dose for it to work effectively – all at a time when every second matters in order to save a life.
In fact, the U.S. Food and Drug Administration (FDA) recently held a joint advisory meeting where a majority of the experts there voted in favor of increasing the how much naloxone is given initially in an emergency overdose situations in the community setting – meaning non-medical areas like someone’s home, i.e. the place where a majority of opioid-related overdoses are occurring.
Accordingly, it’s essential that the available products and devices provide consistent and adequate dosages of naloxone and must be readily, rapidly and safely administered by a witness, like a friend or family member, in the home. This is where I believe we can make a difference now by providing a stronger recommended dose for all naloxone devices and products intended for community use to ensure they are effective.
As momentum grows in providing larger access to naloxone, it is important to understand that higher doses of naloxone that are currently FDA-approved and on the market have proved to be safe in trials. These devices are hassle-free and easy-to-use, making them ideal in overcoming today’s opioid overdoses.
With any shift in medical treatment comes its critics. Some advisory committee members and participants voiced concern over potential acute withdrawal symptoms associated with higher doses of naloxone. In my experience, these effects are minimal, not life-threatening and, essentially, temporary. Death and serious brain injury however, are not.
Members and participants in the advisory committee also expressed a desire for more data on the community use and effects of higher naloxone dosage. While controlled studies and clinical trials are the typical processes by which the FDA assesses proper dosing standards, people are dying today, and there exists real-life, community-collected evidence that higher naloxone dosages are working effectively without issue. Administering a higher dose will help prevent these tragedies from continuing to pile up. Standardizing community access to higher dose naloxone is critical in our work to save lives now.
If we are not able to update the current standard of care in the immediate future, it is extremely important that our Congressional leaders at the federal and state levels push our regulators to do so. Additionally, it is critical our federal legislators call upon their own state leadership to standardize dosing to make an immediate difference in saving lives.
Accordingly, we can ensure access to and availability of naloxone at a strong enough dose to match the opioid overdose epidemic that continues to plague our communities. The FDA advisory committee’s recommendation was a beginning step towards saving lives, it is now up to our leaders in Washington to help make this recommendation a reality.
Dr. Shawn Ryan is an Assistant Professor and Physician of Emergency Medicine at University of Cincinnati Medical Center. He is also President of the Ohio Chapter of the American Society of Addiction Medicine as well as President and CMO of BrightView, LLC.
The views expressed by contributors are their own and not the views of The Hill.