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Data collected from postmarketing use of REVIA show that most events usually occur early in the course of drug therapy and are transientIt is not always possible to distinguish these occurrences from those signs and symptoms that may result from a withdrawal syndromeEvents that have been reported include anorexiaastheniachest painfatigueheadachehot flushesmalaisechanges in blood pressureagitationdizzinesshyperkinesianauseavomitingtremorabdominal paindiarrheapalpitationsmyalgiaanxietyconfusioneuphoriahallucinationsinsomnianervousnesssomnolenceabnormal thinkingdyspnearashincreased sweatingvision abnormalitiesand idiopathic thrombocytopenic purpura.

After opioid detoxificationpatients are likely to have reduced tolerance to opioidsAs the blockade of exogenous opioids provided by REVIA wanes and eventually dissipates completelypatients who have been treated with REVIA may respond to lower doses of opioids than previously usedjust as they would shortly after completing detoxification.

In the clinical studiestreatment with REVIA supported abstinenceprevented relapse and decreased alcohol consumptionIn the uncontrolled studythe patterns of abstinence and relapse were similar to those observed in the controlled studiesREVIA was not uniformly helpful to all patientsand the expected effect of the drug is a modest improvement in the outcome of conventional treatment.

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.

Studies to evaluate possible interactions between REVIA and drugs other than opiates have not been performedConsequentlycaution is advised if the concomitant administration of REVIA and other drugs is required.

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