Duloxetine Hydrochloride (Page 7 of 15)

6.11 Adverse Reactions Observed in Children and Adolescent Placebo-Controlled Clinical Trials

The adverse drug reaction profile observed in pediatric clinical trials (children and adolescents) was consistent with the adverse drug reaction profile observed in adult clinical trials. The specific adverse drug reactions observed in adult patients can be expected to be observed in pediatric patients (children and adolescents) [see Adverse Reactions (6.5)]. The most common (≥5% and twice placebo) adverse reactions observed in pediatric clinical trials include: nausea, diarrhea, decreased weight, and dizziness.

Table 6 provides the incidence of treatment-emergent adverse reactions in pediatric placebo- controlled trials that occurred in greater than 2% of patients treated with duloxetine and with an incidence greater than placebo.

Table 6: Treatment-Emergent Adverse Reactions: Incidence of 2% or More and Greater than Placebo in three 10- week Pediatric Placebo-Controlled Trialsa
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 abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain.
c Also includes asthenia.
d Frequency based on weight measurement meeting potentially clinically significant threshold of ≥3.5% weight loss
(N=467 duloxetine; N=354 Placebo).
e Also includes hypersomnia and sedation.
f Also includes initial insomnia, insomnia, middle insomnia, and terminal insomnia.
Percentage of Pediatric Patients Reporting Reaction
System Organ Class / Adverse Reaction Duloxetine ( N = 476 ) Placebo ( N = 362 )
Gastrointestinal Disorders
Nausea 18 8
Abdominal Painb 13 10
Vomiting 9 4
Diarrhea 6 3
Dry Mouth 2 1
General Disorders and Administration Site Conditions
Fatiguec 7 5
Decreased Weightd 14 6
Metabilism and Nutrition Disorders
Decreased Appetite 10 5
Nervous System Disorders
Headache 18 13
Somnolence 11 6
Dizziness 8 4
Psychiatric Disorders
Insomniaf 7 4
Respiratory , Thoracic , and Mediastinal Disorders
Oropharyngeal Pain 4 2
Cough 3 1

Other adverse reactions that occurred at an incidence of less than 2% but were reported by more duloxetine treated patients than placebo treated patients and are associated duloxetine treatment: abnormal dreams (including nightmare), anxiety, flushing (including hot flush), hyperhidrosis, palpitations, pulse increased, and tremor.

Discontinuation-emergent symptoms have been reported when stopping duloxetine delayed-release capsules. The most commonly reported symptoms following discontinuation of duloxetine in pediatric clinical trials have included headache, dizziness, insomnia, and abdominal pain [see Warnings and Precautions (5.7) and Adverse Reactions (6.2)].

Growth (Height and Weight) — Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. In studies up to 9 months, duloxetine-treated pediatric patients experienced an increase in height of 1.7 cm on average (2.2 cm increase in children [7 to 11 years of age] and 1.3 cm increase in adolescents [12 to 17 years of age]). While height increase was observed during these studies, a mean decrease of 1% in height percentile was observed (decrease of 2% in children [7 to 11 years of age] and increase of 0.3% in adolescents [12 to 17 years of age]). Weight and height should be monitored regularly in children and adolescents treated with duloxetine.

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.

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