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SAFETY OF MOCLOBEMIDE IN CLINICAL USE

The reversible monoamine oxidase-A (MAO-A) inhibitors were developed by researchers in response to safety concerns about the old irreversible MAO inhibitors. Scientists devised this new class of MAO-A inhibitors with the hope that selectivity for the MAO-A receptor and reversibility of the inhibition would result in efficacy in depression with improved safety. Moclobemide is the first reversible MAO-A inhibitor to be widely marketed and is currently approved for marketing in approximately 50 countries. In determining the safety profile of a drug, the following strategy is generally employed by a manufacturer: (a) comparison of the drug to placebo in clinical trials to identify the more commonly occurring adverse reactions; (b) comparison of the drug to other known drugs in clinical trials to determine relative frequencies of adverse reactions; (c) examination of reports from practitioners, the so-called spontaneously reported adverse event reports to confirm that what is seen under the experimental conditions of clinical trials is also seen in "real life" and to generate hypotheses about rare adverse reactions to the drug; (d) identification of further adverse reactions from overdose reports; and (e) the conduct of postmarketing studies to further determine drug-drug interactions. Such a strategy was employed by the manufacturer for moclobemide, and this article reviews the results of data accumulated concerning moclobemide safety.