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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.
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.
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.
In premarketing clinical trials for conditions other than PMDD2 patients are known to have developed a serious cutaneous systemic illnessIn neither patient was there an unequivocal diagnosisbut one was considered to have a leukocytoclastic vasculitisand the othera severe desquamating syndrome that was considered variously to be a vasculitis or erythema multiformeOther patients have had systemic syndromes suggestive of serum sickness.
Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indicationsboth psychiatric and nonpsychiatricshould be alertedabout 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.
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