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There was limited evidence of a weak genotoxic effect of naltrexone in one gene mutation assay in a mammalian cell linein the Drosophila recessive lethal assayand in non-specific DNA repair tests with EcoliHoweverno evidence of genotoxic potential was observed in a range of other in vitro testsincluding assays for gene mutation in bacteriayeastor in a second mammalian cell linea chromosomal aberration assayand an assay for DNA damage in human cellsNaltrexone did not exhibit clastogenicity in an in vivo mouse micronucleus assay.

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In every casehealthcare providers should always be prepared to manage withdrawal symptomatically with non-opioid medications because there is no completely reliable method for determining whether a patient has had an adequate opioid-free periodA naloxone challenge test may be helpfulhowevera few case reports have indicated that patients may experience precipitated withdrawal despite having a negative urine toxicology screen or tolerating a naloxone challenge testusually in the setting of transitioning from buprenorphine treatmentPatients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid usePatients treated for alcohol dependence with REVIA should also be assessed for underlying opioid dependence and for any recent use of opioids prior to initiation of treatment with REVIAPrecipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids.

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