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No suicides occurred in any of the pediatric trialsThere were suicides in the adult trialsbut the number was not sufficient to reach any conclusion about drug effect on suicide.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trialsSimilarlythe cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatmentsusesand investigatorsThe cited figureshoweverdo provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Electrocardiograms from CelexaN=802and placeboN=241groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-doseand subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25change from baselinetachycardic or bradycardic outliersrespectivelyIn the Celexa group 1.9of the patients had a change from baseline in QTcF60 msec compared to 1.2of the patients in the placebo groupNone of the patients in the placebo group had a post-dose QTcF500 msec compared to 0.5of the patients in the Celexa groupThe incidence of tachycardic outliers was 0.5in the Celexa group and 0.4in the placebo groupThe incidence of bradycardic outliers was 0.9in the Celexa group and 0.4in the placebo group.

In some casesa patient already receiving Celexa therapy may require urgent treatment with linezolid or intravenous methylene blueIf acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patientCelexa should be stopped promptlyand linezolid or intravenous methylene blue can be administeredThe patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene bluewhichever comes firstTherapy with Celexa may be resumed 24 hours after the last dose of linezolid or intravenous methylene bluesee WARNINGS

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