rse reactions are described below and elsewhere in the labeling:
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)]
Hepatotoxicity [see Warnings and Precautions (5.2)]
Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3)]
Serotonin Syndrome [see Warnings and Precautions (5.4)]
Abnormal Bleeding [see Warnings and Precautions (5.5)]
Severe Skin Reactions [see Warnings and Precautions (5.6)]
Discontinuation of Treatment with duloxetine delayed-release capsules [see Warnings and Precautions (5.7)]
Activation of Mania/Hypomania [see Warnings and Precautions (5.8)]
Angle-Closure Glaucoma [see Warnings and Precautions (5.9)]
Seizures [see Warnings and Precautions (5.10)]
Effect on Blood Pressure [see Warnings and Precautions (5.11)]
Clinically Important Drug Interactions [see Warnings and Precautions (5.12)]
Hyponatremia [see Warnings and Precautions (5.13)]
Urinary Hesitation and Retention [see Warnings and Precautions (5.15)]
6.1 Clinical Trial Data Sources
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline eva luation. Reactions reported during the studies were not necessarily caused by the therapy, and the frequencies do not reflect investigator impression (assessment) of causality.
Adults — The data described below reflect exposure to duloxetin in placebo-controlled trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), DPNP (N=906), and another indication (N=1294). The population studied was 17 to 89 years of age; 65.7%, 60.8%, 60.6%, 42.9%, and 94.4% female; and 81.8%, 72.6%, 85.3%, 74.0%, and 85.7% Caucasian for MDD, GAD, OA and CLBP, DPNP, and another indication, respectively. Most patients received doses of a total of 60 to 120 mg per day [see Clinical Studies (14)].
Information describing two additional clinical studies in which efficacy was not demonstrated in patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. Other pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
6.2 Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Adult Placebo-Controlled Trials
Major Depressive Disorder — Approximately 8.4% (319/3779) of the patients who received duloxetine in placebo-controlled trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of the patients receiving placebo. Nausea (duloxetine 1.1%, placebo 0.4%) was the only commo
