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The effectiveness of sarafem for the treatment of pmdd was established in 3 placebo-controlled trials 1 intermittent and 2 continuous dosing .

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Because fluoxetine is tightly bound to plasma proteinsthe administration of fluoxetine to a patient taking another drug that is tightly bound to proteinfor examplewarfarindigitoxinmay cause a shift in plasma concentrations potentially resulting in an adverse effectsee CLINICAL PHARMACOLOGY

There are no clinical studies establishing the benefit of the combined use of ECT and fluoxetineThere have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment.

Anaphylactoid reactionsincluding bronchospasmangioedemalaryngospasmand urticaria alone and in combinationhave been reported.

Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking SARAFEM.

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