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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.

Rarelymales may have a painful or prolonged erection lasting 4 or more hoursIf this occursstop using this drug and get medical help right awayor permanent problems could occur.

It should be noted that the diagnosis of PMDD does exist during pregnancyFluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetusAll pregnancies have a background risk of birth defectslossor other adverse outcome regardless of drug exposure.

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

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It should be noted that SARAFEM is not approved for treating any indication in the pediatric population.

If the decision has been made to discontinue treatmentmedication should be taperedas rapidly as is feasiblebut with recognition that abrupt discontinuation can be associated with certain symptomssee Discontinuation of Treatment

Concomitant use of SARAFEM in patients taking thioridazine is contraindicatedThioridazine should not be administered with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinuedsee CONTRAINDICATIONS

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Patients should be advised to take SARAFEM exactly as prescribedand to continue taking SARAFEM as prescribed even after their symptoms improvePatients should be advised that they should not alter their dosing regimenor stop taking SARAFEM without consulting their physiciansee WARNINGS AND PRECAUTIONSPatients should be advised to consult with their healthcare provider if their symptoms do not improve with SARAFEM.

Drugs That Interfere With Hemostasisfor exampleNSAIDSAspirinWarfarin)

There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant womenResults of a number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent resultsMore than 10 cohort studies and case-control studies failed to demonstrate an increased risk for congenital malformations overallHoweverone prospective cohort study conducted by the European Network of Teratology Information Services reported an increased risk of cardiovascular malformations in infants born to womenN253exposed to fluoxetine during the first trimester of pregnancy compared to infants of womenN1359who were not exposed to fluoxetineThere was no specific pattern of cardiovascular malformationsOverallhowevera causal relationship has not been established.

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