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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.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapyFluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetussee Use In Specific Populations
A lower or less Frequent dosage should be used in patients with hepatic impairmentsee CLINICAL PHARMACOLOGY and Use in Specific Populations
Anxietynervousnessand insomnia were associated with discontinuation for SARAFEMsee Table 4 and Discontinuation of Treatment
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