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No suicides occurred in any of the pediatric trialsThere were suicides in the adult trialsbut the number was not sufficient to reach any conclusion about drug effect on suicide.
Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy.
In the tables and tabulations that followCOSTART Dictionary terminology has been used to classify reported adverse reactionsThe stated frequencies represent the proportion of individuals who experiencedat least oncea treatment-emergent adverse reaction of the type listedA reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluationIt is important to emphasize that reactions reported during therapy were not necessarily caused by it.
Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.
SARAFEM is indicated for the treatment of premenstrual dysphoric disorderPMDDsee Clinical Studies
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