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Adverse Reactions Occurring At An Incidence Of 2Or More Among CYMBALTA-Treated Patients In Adult Placebo-Controlled Trials.
Changes in sexual desiresexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetesbut they may also be a consequence of pharmacologic treatmentBecause adverse sexual reactions are presumed to be voluntarily underreportedthe Arizona Sexual Experience ScaleASEXa validated measure designed to identify sexual side effectswas used prospectively in 4 MDD placebo-controlled trialsIn these trialsas shown in Table 5 belowpatients treated with CYMBALTA experienced significantly more sexual dysfunctionas measured by the total score on the ASEXthan did patients treated with placeboGender analysis showed that this difference occurred only in malesMales treated with CYMBALTA experienced more difficulty with ability to reach orgasmASEX Item 4than males treated with placeboFemales did not experience more sexual dysfunction on CYMBALTA than on placebo as measured by ASEX total scoreNegative numbers signify an improvement from a baseline level of dysfunctionwhich is commonly seen in depressed patientsPhysicians should routinely inquire about possible sexual side effects.
The stated frequencies of adverse reactions 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 evaluationReactions reported during the studies were not necessarily caused by the therapyand the frequencies do not reflect investigator impressionassessmentof causality.
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CYMBALTA treatment in placebo-controlled clinical trials across approved indicationswas associated with small mean increases from baseline to endpoint in ALTASTCPKand alkaline phosphataseinfrequentmodesttransientabnormal values were observed for these analytes in CYMBALTA-treated patients when compared with placebo-treated patientssee WARNINGS AND PRECAUTIONSHigh bicarbonatecholesteroland abnormalhigh or lowpotassiumwere observed more frequently in CYMBALTA treated patients compared to placebo.
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