Cymbalta: US FDA label indications

Indications and usage (label excerpt)

INDICATIONS & USAGE Cymbalta ® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Generalized Anxiety Disorder (GAD) ( 1.2 ) Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) Fibromyalgia (FM) ( 1.4 ) Chronic Musculoskeletal Pain ( 1.5 ) Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short-term and one maintenance trial in adults [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta was established in three short-term trials and one maintenance trial in adults [see Clinical Studies ( 14.2 )] . Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause signi…

Warnings (label excerpt)

WARNINGS AND PRECAUTIONS Suicidality: Monitor for clinical worsening and suicide risk ( 5.1 ) Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Cymbalta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy ( 5.3 ) Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with Cymbalta, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue Cymbalta and initiate supportive treatment. …

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Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.