Recall issued for device that delivers overdose reversal drug Naloxone

Posted at 3:23 PM, Nov 05, 2016
and last updated 2016-11-05 17:29:38-04

By Nadia Kounang


(CNN) — Naloxone, the opioid overdose antidote, has become a vital tool in fighting the heroin and opioid epidemic. It can be administered with a syringe-like device that sprays the drug into the nose. But a voluntary recall has been issued by the manufacturer of the device, Teleflex.

In a letter (PDF) sent to distributors of the product this week, Teleflex said it was recalling internasal mucosal atomizer devices because “they may not deliver a fully atomized plume of medication. Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray.”

As a result, the drug isn’t as effective. As Boston Children’s Hospital pharmacist Shannon Manzi explained, “less surface area covered, less complete absorption.”

According to Jake Elguicze of Teleflex, as of October 27, the company has received six complaints and no reports of serious injury or death.

Although Teleflex has notified the Food and Drug Administration of the recall, the use of the atomizer to administer naloxone is an off-label use, so related adverse events are not required to be reported.

The recall affects over 66 batches that have been distributed nationally.

Dr. Ed Boyer, professor of emergency medicine at the University of Massachusetts Medical School, has seen their failure firsthand but says the potency of the drug on the street amplifies the consequences.

“We’ve had several failures of multiple doses,” he said. “I’ve wondered if device failure could contribute, but the reality is that the growing presence of high-potency opioids (e.g. fentanyl) demands that full doses be optimally delivered if successful reversal of poisoning is to (be) achieved.”

According to the US Centers for Disease Control and Prevention, since 2000, there has been a 200% increase in the rate of opioid overdose deaths; this includes heroin as well as prescription narcotics. Drug overdoses are the leading cause of accidental death in the US.

In an effort to stymie that rate, naloxone has been made more available to law enforcement, paramedics and community members. In addition, between 1996 and 2014, at least 152,000 naloxone kits have been distributed to non-medical and non-first responder individuals. At least 26,000 overdoses were reversed with those kits