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Fluoxetine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart diseasePatients with these diagnoses were systematically . excluded from clinical studies during the product’s premarket testingHoweverthe electrocardiograms of 312 patients who received fluoxetine in double-blind trialsfor a condition other than PMDDwere retrospectively evaluatedno conduction abnormalities that resulted in heart block were observedThe mean heart rate was reduced by approximately 3 beats/min.

In some casesa patient already receiving SARAFEM 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 patientSARAFEM should be stopped promptlyand linezolid or intravenous methylene blue can be administeredThe patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene bluewhichever comes firstTherapy with SARAFEM may be resumed 24 hours after the last dose of linezolid or intravenous methylene bluesee WARNINGS AND PRECAUTIONS

You should see some improvement in 1 to 2 weeksIt may take 4 to 5 weeks before you feel the full benefit.

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.

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