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Starting sarafem in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome see dosage and administration 2.

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Several SSRIsegfluoxetinefluvoxamineparoxetinesertralineare metabolized by CYP2D6.

Antidepressants increased the risk compared to placebo of suicidal thinking and behaviorsuicidalityin childrenadolescentsand young adults in short-term studies of Major Depressive DisorderMDDand other psychiatric disordersAnyone considering the use of SARAFEM or any other antidepressant in a childadolescentor young adult must balance this risk with the clinical needShort-term studies did not s how an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and olderDepress ion and certain other psychiatric disorders are themselves associated with increases in the risk of suicidePatients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worseningsuicidalityor unusual changes in behaviorFamilies and caregivers should be advised of the need for close observation and communication with the prescriberSARAFEM is not approved for us e in pediatric patientssee WARNINGS AND PRECAUTIONS and Use in Specific Populations

Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indicationsboth psychiatric and nonpsychiatricshould be alerted about the need to monitor patients for the emergence of agitationirritabilityunusual changes in behaviorand the other symptoms described aboveas well as the emergence of suicidalityand to report such symptoms immediately to health care providersSuch monitoring should include daily observation by families and caregiversPrescriptions for SARAFEM should be written for the smallest quantity of tablets consistent with good patient managementin order to reduce the risk of overdose.

The impact of CYP2D6 activity is further complicated by some SSRIsegfluoxetinefluvoxamineparoxetinesertralinethatin addition to being substrates for CYP2D6are also known to moderately inhibit CYP2D6 activity.

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

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