The Clozaril National Registry (CNR) was created to help protect patients from developing potentially fatal agranulocytosis secondary to treatment with the antipsychotic medicine clozapine.
The CNR, designed and maintained by the manufacturer of the branded Clozaril (clozapine), has the principal goals of (1) prophylaxis-preventing inappropriate retreatment, and (2) quality assurance-overseeing adherence to a « no blood, no drug » policy.
This article reviews the estimated impact of the CNR on clozapine-related morbidity and mortality over the first 5 years of commercial experience in the United States.
Complete data on leukopenia and agranulocytosis, gathered from the CNR database for the period of 1990-1994, were reviewed and compared with data from the pre-CNR period.
Use of clozapine in 99,502 patients according to package labeling requirements (distribution of the medicine linked to mandated white blood cell count testing) was associated with a total of 382 cases of agranulocytosis (0.38%) versus an expected cumulative total of 995 cases (based on the pre-CNR rate of 1% to 2%). Based on the expected agranulocytosis rate, up to 149 deaths might have been anticipated.
Instead, there were only 12 deaths attributed to complications of agranulocytosis.
The CNR provides for universal rechallenge protection as well as controlled dispensing of clozapine. (...)
Mots-clés Pascal : Clozapine, Neuroleptique, Atypique, Psychotrope, Prévention, Toxicité, Agranulocytose, Epidémiologie, Etats Unis, Amérique du Nord, Amérique, Mortalité, Assurance qualité, Homme, Hémopathie, Neutropénie, Leucopénie
Mots-clés Pascal anglais : Clozapine, Neuroleptic, Atypical, Psychotropic, Prevention, Toxicity, Agranulocytosis, Epidemiology, United States, North America, America, Mortality, Quality assurance, Human, Hemopathy, Neutropenia, Leukopenia
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0335431
Code Inist : 002B02B03. Création : 27/11/1998.