Letters to the Editor
Reply: From Chlorpromazine to Clozapine—
Antipsychotic Adverse Effects and the Clinician’s Dilemma
Dear Editor:
We thank Dr Nardi for his comments, which underscore the points we made and the challenges we face in treating schizophrenia.
In evaluating the personal, social, and economic burden of schizophrenia, we need to consider not only the immediate gains but also the long-term sequelae of pharmacotherapy.
Regulatory bodies such as Canada’s Therapeutic Products Directorate, the US Food and Drug Administration, and other similar agencies usually base their approval for antipsychotic drugs on a few Phase III clinical trials, where the study drug or treatment is given to large groups of people (approximately 1000 to 3000) to confirm its effectiveness, monitor its side effects, compare it with commonly used treatments, and collect information that will allow it to be used safely. In most cases, these are short-term, double-blind, placebo-controlled trials. Further, in seeking approval, pharmaceutical firms are not obligated to submit all data (both positive and negative) from Phase III clinical trials. Therefore, continued post-marketing vigilance and surveillance play a crucial role in evaluating long-term risks and benefits.
Srinivasa M Bhaskara, MB, FRCPC, MRCPsych
S Abidi, MD
Lower Sackville, Nova Scotia
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