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Anxietynervousnessand insomnia were associated with discontinuation for SARAFEMsee Table 4 and Discontinuation of Treatment

Healthcare providers should inform patientstheir familiesand their caregivers about the benefits and risks associated with treatment with SARAFEM and should counsel them in its appropriate useHealthcare providers should instruct patientstheir familiesand their caregivers to read the Medication Guide and should assist them in understanding its contentsPatients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Serotonin release by platelets plays an important role in hemostasisEpidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleedingAltered anticoagulant effectsincluding increased bleedinghave been reported when SNRIs or SSRIs are coadministered with warfarinPatients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinuedsee WARNINGS AND PRECAUTIONS

The following adverse reactions have been identified during post approval use of fluoxetineBecause these reactions are reported voluntarily from a population of uncertain sizeit is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

Healthcare providers should inform patientstheir familiesand their caregivers about the benefits and risks associated with treatment with SARAFEM and should counsel them in its appropriate useHealthcare providers should instruct patientstheir familiesand their caregivers to read the Medication Guide and should assist them in understanding its contentsPatients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

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