Are Naltrexone Implants safe enough?
According to the two articles, published in the latest Medical Journal of Australia, an urgent analysis of the use of naltrexone for heroin and alcohol dependence is required as there are reports of harmful and unpleasant reactions.
Opioid dependence
Associate Professor Robert Ali, Director of the Drug Alcohol Services Council in Adelaide, and his co-authors stated that because of naltrexone‘s inexpensive, long-acting and usually well accepted effects it is considered a striking treatment for opioid dependence.
Oral naltrexone is used as a cure for heroin and alcohol dependence
Naltrexone implants
However, the success and safety of oral treatments is related to poor patient observance to taking regular doses.This has led to the expansion of long-acting naltrexone implants and storing injections.
Naltrexone implants have not been permitted for human use in Australia, but these implants are being supplied through some private clinics.
Assoc. Prof. Ali says that naltrexone implants are now acquired through the TGA Special Access Scheme but without the product being subjected to the typical thorough analysis for new devices in Australia.
In a linked study issued in the journal, Dr Paul Haber, Head of Drug Health Services at Royal Prince Alfred Hospital, and his co-authors examined 12 patients who were admitted to hospital shortly after getting naltrexone in oral or implant form.
Stern opiate extraction and dehydration
Eight of the cases were absolutely or possibly associated to the naltrexone implant, together with cases of stern opiate extraction and dehydration, infection at the implant site requiring surgical treatment, and a psychiatric disorder.
A safe process?
The authors said these severe undesirable events defy the view that naltrexone implants are a safe process.
“These events propose a need for cautious case selection, vigilant clinical management, and for closer regulatory checking to save this marginalized and exposed population,” Dr Haber stated.
“Patients must be advised of the related risks, and suitable measures must be intended to counter with any difficulty.”
Screening patients
Dr Haber also stressed the significance of screening patients for primary medical or psychiatric conditions and, significantly, coordinating with related service suppliers.
“In the same way, a close association between naltrexone implant suppliers and local emergency departments is important.”
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