Naloxone is an opioid overdose antidote, which has become a highly popular tool in fighting the effects of heroin abuse. However, Teleflex, the manufacturer of the nasal spray device, sent a letter to all its distributors at the beginning of November, stating that the intranasal mucosal atomization devices will be recalled.
The antidote was known for its efficiency, as it can be administered through the said device similar to a syringe spraying the drug inside the nose of the user. The rate of opioid overdose deaths has increased to 200 percent since 2000 among heroin and prescription narcotics users, according to the data from the U.S. Centers for Disease Control and Prevention.
This situation makes overdoses the main cause for accidental deaths in the United States. In the attempt to decrease the rate, naloxone was produced on a larger scale, being available to law enforcement as well as the members of community and paramedics.
At least 152,000 naloxone kits were distributed between the interval starting 1996 to 2014 to non-medical people. The number of overdoses that were reversed with the naloxone kits reached 26,000 within that period.
Atomization Device Inefficiency And Complaints
Teleflex has willingly recalled the nasal spray device, stating that its effectiveness was no longer within the initially established parameters. There were six complaints, as of Oct. 27, regarding the lack of efficiency of the product, although none of them resulted in death or serious injuries.
The Food and Drug Administration (FDA) was also notified about the recall, as the atomizer decreased in efficiency, and adverse effects were reported.
"The FDA is working with Teleflex to assess its voluntary medical device recall and the impact that this recall is having on its customers. The agency will share information with the public about this recall, including its classification, as appropriate," stated Michael Felberbaum, FDA Press Officer.
"[T]hey 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," stated the letter.
Teleflex Medical explained, as part of the urgent letter, that the devices it has recalled could fail to deliver the atomized plume of the medication. The company stated that the complaints it has received accused the device of producing a straight stream of the medication instead of a spray.
According to the state Health Department, providers, pharmacists and police agencies were all alerted about the recall of the product, as the company's efforts will be focused on determining the scope of the recall of the distributed kits.
The ACR Health of Syracuse, an organization operating the syringe program, has already distributed more than 1,200 kits in Central New York, saying that they are not affected by the recall, therefore still being safe to use despite of the official position of Teleflex.