Naloxone, the opioid overdose antidote, has grown to be a significant tool in battling the heroin and opioid epidemic. It can be applied with a syringe-like device that sprays the drug into the nostril. However a voluntary recall has been released by the manufacturer of the device, Teleflex.
Teleflex said it was recalling internasal mucosal atomizer devices due to the fact “they might not provide a fully atomized plume of medication. Teleflex Medical has received complaints that the affected lots produced a straight stream as opposed to an atomized spray.”
Because of this, the drug is not 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 without any reports of significant injury or death.
However Teleflex has informed 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 necessary to be reported.
The recall impacts over 66 batches that had been distributed nationally.
Dr. Ed Boyer, professor of emergency medicine at the University of Massachusetts Medical School, has observed their failure firsthand but states 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.”
As per the US Centers for Disease Control and Prevention, since 2000, there have been a 200% boost in the rate of opioid overdose deaths ; which includes heroin in addition to prescription narcotics. Drug overdoses are the leading source of accidental death in the United States.
In an effort to stymie that rate, naloxone has been made much more accessible to law enforcement, paramedics and local community members. Additionally, between 1996 and 2014, at least 152,000 naloxone kits have already been distributed to non-medical and non-first responder individuals. A minimum of 26,000 overdoses were reversed with those kits.