Tuesday, November 22, 2011

FDA to Ponder Naloxone for Overdose Rescue

Rescue NaloxoneWe have previously written in these UPDATES about naloxone for overdose rescue [eg, here and here] and in a journal article [PDF here]. Naloxone is an opioid antagonist that has been approved and used in the U.S. since 1971 as an antidote to respiratory failure during opioid overdose, primarily by emergency medical personnel. Today, there is considerable evidence that this agent can be administered by practically anyone in the event of such emergencies and has significant lifesaving potential.

FINALLY, the U.S. Food and Drug Administration (FDA) is ready to listen to arguments in favor of wider distribution and use of naloxone. They will be hosting a meeting next spring — April 12, 2012 — titled “The Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop” [see details and what you can do below]. One impetus for this might have been recent reports from the Centers for Disease Control and Prevention (CDC) noting that opioid-related deaths have been rising steeply and reached nearly 15,000 in 2008 [see UPDATE here].

Various programs, such as Project Lazarus [UPDATE here], have already demonstrated the feasibility and lifesaving value of naloxone distribution to persons prescribed opioid analgesics. The purpose of the FDA meeting is to “discuss whether naloxone should be made more widely available to trained, non-healthcare individuals in an effort to significantly reduce deaths due to opioid overdose.”

The preliminary agenda for the meeting is available for download at Pain-Topics.org [PDF here]. A panel of experts will discuss at-risk populations for opioid overdose, ongoing attempts by public health groups to curb the abuse of opioids, and issues pro and con related to wider naloxone availability. A brief period will be allowed for comments from the audience.

Meeting logistics are described in the Federal Register Notice (2011(Nov 17);76(222):71348) [PDF here]. Attendance at the April 12th meeting, to be held just outside of Washington DC in Silver Spring, Maryland, is open to the public but seating will be limited. Meanwhile, any interested persons or organizations can electronically submit comments online until June 12, 2012 at Docket No. FDA-2011-N-0802 [here].

We would encourage healthcare professionals, advocacy organizations, and patients with pain to at least submit a comment. There is much at stake since, unless the tragic incidences of overdose deaths related to opioid analgesics can be stemmed, government agencies at all levels will continue to seek ways of curtailing prescribing of these vital medications. Naloxone is a relatively inexpensive and effective solution that can be easily administered by anyone with only about 10 minutes of training (especially, if an intranasal formulation is approved). This meeting organized by the FDA is long overdue and the delay until next spring is disappointing, but we must concede, “better later than never.”