Opioid Antidote Naloxone Recalled by Manufacturer

Drug manufacturer Hospira has recalled Naloxone, the medication commonly used by first responders, medical professionals, and hospitals to quickly reverse suspected conditions of an opioid overdose. The National Institute on Drug Abuse states that Naloxone works as an opioid antagonist, attaching to opioid receptors in the brain. Therefore, when it is administered to a drug overdose victim, it works quickly to recover respiration when breathing has slowed down or ceased completely from the effect of the opioids.

Reason for the recall

The recall of Naloxone, announced by the Federal Drug Administration (FDA), was related to the possibility of loose particulate matter resting on the syringe plunger, potentially initiating certain adverse conditions. Although the likelihood is low, some of the possible negative symptoms and conditions resulting from exposure to the particulate matter include:

• Allergic responses
• Local irritation
• Pulmonary emboli
• End-organ granuloma
• Pulmonary infarction
• Tissue ischemia
• Phlebitis
• Toxicity
• Pulmonary dysfunction

 

Although no problems have yet to be reported with the drug, Pfizer, the parent company of Hospira, issued a recall as a preventative measure. The potential introduction of the particulate matter would make this very beneficial antidote, in essence, a dangerous drug to the recipient.

Naloxone Hydrochloride is available in the marketplace for subcutaneous, intramuscular, and IV use. The specific products affected by the recall include single use sterile cartridges having lot numbers 76510LL and 72680LL in strengths of 0.4 mg/ml, 1 ml in, and 2.5 ml. These products were disseminated to hospitals, distributors, wholesalers in the U.S., Guam, and Puerto Rico between February 2017 and February 2018.

Pfizer told NBC there is currently no shortage of Naloxone because it is currently offered in vials. As well, the recall does not pertain to other Naloxone products offered under the Narcan brand name.

According to the FDA, Hospira has contacted hospitals, wholesalers, distributors that possess the contaminated lots and is advising others to throw away any affected lots.

History of Naloxone

Initially created in 1961, Naloxone produced results quickly and was established as an effective antidote to reverse the deadly effects of opioid overdose. The drug also has little to zero side effects and resides within a person’s system for about an hour and a half.

Dr. Thomas Waters of the Cleveland clinic told Health.com, “The sooner the drug is given, the better the result, because the brain of a person who isn’t breathing is being deprived of oxygen.” The drug only reverses opioid overdoses, however. It does not reverse non-opioid or alcohol overdoses.

If you know or suspect that you have suffered a serious injury due to the use of Naloxone, you have the legal right to seek justice and financial compensation for your losses, including any pain and suffering you have experienced. At McGowan, Hood, Felder & Phillips, LLC, our experienced dangerous drug attorneys can review your case and take direct action to hold any liable parties to account, including medical providers and drug manufacturers. To set up a free, no-obligation consultation to discuss your case, call us today at 803-327-7800 or send us a request through our contact form.