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A major depressive episode may be the initial presentation of Bipolar DisorderIt is generally believedthough not established in controlled trialsthat treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for Bipolar DisorderWhether any of the symptoms described for clinical worsening and suicide risk represent such a conversion is unknownHoweverprior to initiating treatment with an antidepressantpatients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disordersuch screening should include a detailed psychiatric historyincluding a family history of suicideBipolar Disorderand depressionIt should be noted that SARAFEM is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.

Safety and effectiveness of SARAFEM in the pediatric population have not been establishedsee BOXED WARNING and WARNINGS AND PRECAUTIONSWhen considering the use of SARAFEM in a child or adolescentthe potential risks must be balanced with the clinical needSignificant toxicityincluding myotoxicitylong-term neurobehavioral and reproductive toxicityand impaired bone developmenthas been observed following exposure of juvenile animals to fluoxetineSome of these effects occurred at clinically relevant exposures.

Get emergency medical help if you have any of these signs of an allergic reactionskin rash or hivesdifficulty breathingswelling of your facelipstongueor throat.

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