Evaluation of an Interchangeability Switch in Patients Treated With Clozapine: A Retrospective Review
J Clin Psychiatry 2006;67(7):1047-1054
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: To report the findings of a
switch from brand-name to generic clozapine in a
Canadian outpatient population.
Method: The medical records of 58
outpatients diagnosed with schizophrenia and other psychotic disorders and stabilized on
brand-name clozapine therapy were reviewed
retrospectively. Patients were switched from brand-name to
generic clozapine on their next dispensing supply after September 29, 2003. Data regarding
clozapine dose regimens, physicians' visits,
hospitalizations, and adverse events were collected
from the patients' charts for the 6 months
preceding and the 6 months after the switch from
brand-name to generic clozapine. Relevant
measurement changes in those data associated with the
switch are evaluated.
Results: No significant changes in dose,
number of physician's visits, or hospitalization
rates were observed as a consequence of the switch from brand-name to generic clozapine. In
addition, there were no reported increases in the
frequency of the most common adverse events, including decreases in white blood cell
counts. None of the patients received a
"nonrechallengeable" status, and no discontinuation of
clozapine therapy occurred for any reason (toxicity or
treatment failure) in the 6 months after the
Conclusion: In the current outpatient
population, retrospective evaluation of the
conversion from brand-name clozapine to the first
generic alternative available on the Canadian market
did not reveal any significant treatment changes.