Naloxone Nasal Atomizers Recalled

The manufacturer behind a naloxone nasal spray device issued a voluntary product recall last week, according to CNN. 

Teleflex makes the nasal spray device that can be combined with the anti-overdose drug for easy use. Before the advent of naloxone atomizers, the life-saving drug was typically given in an injection—so the spray represented a user-friendly alternative. (There is no problem with naloxone, the drug itself.) 

But now, Teleflex has discovered that alternative isn’t working quite as well as it should. 

“Teleflex Medical is recalling these products as they may not deliver a fully atomized plume of medication,” the company said in a letter to distributors. “Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray.” 

As a result, less of the drug makes it into the body, decreasing the naloxone’s efficacy. “Less surface area covered, less complete absorption,” explained Shannon Manzi, a pharmacist at Boston Children’s Hospital. In short, one dose might not be enough, even when it otherwise should have been. 

“This can lead to serious injury or death in certain emergency situations,” the company wrote. 

Technically, the combination of naloxone and the Teleflex atomizer is an off-label use, which means Teleflex doesn’t need to report adverse reactions. But that doesn’t mean it’s not a problem.

"We've had several failures of multiple doses," Dr. Ed Boyer, an emergency medicine professor at the University of Massachusetts Medical School told CNN. "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 of Oct. 27, the company had received just six complaints about the defect—none of them resulted in serious injury or death, a Teleflex rep told CNN. 

The recall comes amid an ongoing rise in opioid overdose deaths. Since 2000, the fatal opioid overdose rate has increased by 200%, including both heroin and prescription drugs. As of now, drug overdoses are the number one cause of accidental death in the country. 

To combat that, a growing number of first responders have begun carrying naloxone. And between 1996 and 2014, more than 150,000 naloxone kits were handed out to civilians looking to save lives. 

Atomizers that have been affected by the recall include:

160108 160231 160440 160708 160117 160300 160500 160718 160126 160313 160518 160728

160145 160327 160602 160800 160146 160400 160611 160804 160200 160409 160621 160814

160219 160422 160631 160816 160225 160432 160701 160823

If you have questions about this recall, you can reach Teleflex Customer Service at: 1-866-246-6990.

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