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Transaminase elevations were also observed in other placebo controlled studies in which exposure to REVIA at doses above the amount recommended for the treatment of alcoholism or opioid blockade consistently produced more numerous and more significant elevations of serum transaminases than did placeboTransaminase elevations occurred in 3 of 9 patients with Alzheimer’s Disease who received REVIAat doses up to 300 mg/dayfor 5 to 8 weeks in an open clinical trial.
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.
Clinicians are reminded that there is no completely reliable method for determining whether a patient has had an adequate opioid-free periodA naloxone challenge test may be helpful if there is any question of occult opioid dependenceIf signs of opioid withdrawal are still observed following naloxone challengetreatment with REVIA should not be attemptedThe naloxone challenge can be repeated in 24 hours.
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