Duloxetine (Page 5 of 16)

5.15 Urinary Hesitation and Retention

Duloxetine delayed-release capsules are in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with duloxetine delayed-release capsules, consideration should be given to the possibility that they might be drug-related.
In post marketing experience, cases of urinary retention have been observed. In some instances of urinary retention associated with duloxetine delayed-release capsules use, hospitalization and/or catheterization has been needed.

6 ADVERSE REACTIONS

The following serious adverse 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 Studies Experience

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 evaluation. 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 duloxetine delayed-release capsules in placebo-controlled trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), DPNP (N=906), and FM (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 FM, respectively. Most patients received doses of a total of 60 to 120 mg per day [see Clinical Studies (14)]. The data below do not include results of the trial examining the efficacy of duloxetine delayed-release capsules in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population.
Children and Adolescents — The data described below reflect exposure to duloxetine delayed-release capsules in pediatric, 10-week, placebo-controlled trials for MDD (N=341) and GAD (N=135). The population studied (N=476) was 7 to 17 years of age with 42.4% children age 7 to 11 years of age, 50.6% female, and 68.6% white. Patients received 30 to 120 mg per day during placebo-controlled acute treatment studies. Additional data come from the overall total of 822 pediatric patients (age 7 to 17 years of age) with 41.7% children age 7 to 11 years of age and 51.8% female exposed to duloxetine delayed-release capsules in MDD and GAD clinical trials up to 36-weeks in length, in which most patients received 30 to 120 mg per day.

Most Common Adult Adverse Reactions

Pooled Trials for all Approved Indications — The most commonly observed adverse reactions in duloxetine delayed-release capsules-treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.
Diabetic Peripheral Neuropathic Pain — The most commonly observed adverse reactions in duloxetine delayed-release capsules-treated patients (as defined above) were nausea, somnolence, decreased appetite, constipation, hyperhidrosis, and dry mouth.

Fibromyalgia — The most commonly observed adverse reactions in duloxetine delayed-release capsules-treated patients (as defined above) were nausea, dry mouth, constipation, somnolence, decreased appetite, hyperhidrosis, and agitation.
Chronic Pain due to Osteoarthritis — The most commonly observed adverse reactions in duloxetine delayed-release capsules-treated patients (as defined above) were nausea, fatigue, constipation, dry mouth, insomnia, somnolence, and dizziness. Chronic Low Back Pain — The most commonly observed adverse reactions in duloxetine delayed-release capsules-treated patients (as defined above) were nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue.

Adverse Reactions Occurring at an Incidence of 5% or More Among Duloxetine Delayed-Release Capsules-Treated Patients in Adult Placebo-Controlled Trials

Table 2 gives the incidence of treatment-emergent adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with duloxetine delayed-release capsules and with an incidence greater than placebo.

Table 2: Treatment-Emergent Adverse Reactions: Incidence of 5% or More and Greater than Placebo in Placebo-Controlled Trials of Approved Indicationsa

Adverse Reaction

Percentage of Patients Reporting Reaction

Duloxetine Delayed-Release Capsules (N=8100)

Placebo (N=5655)

Nauseac

23

8

Headache

14

12

Dry mouth

13

5

Somnolencee

10

3

Fatigueb,c

9

5

Insomniad

9

5

Constipationc

9

4

Dizzinessc

9

5

Diarrhea

9

6

Decreased appetitec

7

2

Hyperhidrosisc

6

1

Abdominal painf

5

4

a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
b Also includes asthenia.
c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.
d Also includes initial insomnia, middle insomnia, and early morning awakening.
e Also includes hypersomnia and sedation.f Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and gastrointestinal pain.

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