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The pupillary dilation that occurs following use of many antidepressants and SARAFEM may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

The effect of fluoxetine on labor and delivery in humans is unknownHoweverbecause fluoxetine crosses the placenta and because of the possibility that fluoxetine may have adverse effects on the newbornfluoxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

The following symptomsanxietyagitationpanic attacksinsomniairritabilityhostilityaggressivenessimpulsivityakathisiapsychomotor restlessnesshypomaniaand maniahave been reported in adult and pediatric patients being treated with antidepressants for Major Depressive Disorder as well as for other indicationsboth psychiatric and nonpsychiatricAlthough a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been establishedthere is concern that such symptoms may represent precursors to emerging suicidality.

SARAFEM is indicated for the treatment of premenstrual dysphoric disorderPMDDsee Clinical Studies

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