FDA has expanded the duloxetine indication for the treatment of fibromyalgia in pediatric population (age 13-17 yr).
Duloxetine is now approved for following disorders:
- Major depressive disorder in adults
- Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.
- Diabetic peripheral neuropathic pain in adults.
- Fibromyalgia in adults and pediatric patients 13 years of age and older.
- Chronic musculoskeletal pain in adults.
Recommended Dosage in Pediatric Patients 13 to 17 Years of Age:
- Starting Dose: 30 mg once daily.
- The dosage may be increased to 60 mg once daily based on response and tolerability.
Adverse Reactions in Pediatric Patients 13 to 17 Years Old with Fibromyalgia:
Incidence of 5% or More and Greater than Placebo in a 13-week Placebo-Controlled Trial:
- Decreased Appetite
- Decreased Weight
- Upper Respiratory Tract Infection
This decision is based on the following randomized controlled trial:
Upadhyaya HP et al. Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial. Pediatr Rheumatol Online J. 2019 May 28;17(1):27. PubMed PMID: 31138224; PubMed Central PMCID: PMC6540374. (read article)
- Multisite: US, Argentina, Puerto Rico, and India.
- Randomized to duloxetine or placebo for the 13-week double-blind period.
- Starting duloxetine dose was 30 mg daily
- Target dose of 60 mg daily, as tolerated.
For the primary measure:
- Brief Pain Inventory average pain severity, the mean change was not statistically different between duloxetine and placebo (− 1.62 vs. -0.97, respectively; p = .052).
For secondary efficacy outcomes:
- statistically significantly more duloxetine- versus placebo-treated patients had a treatment response (≥30% and ≥50% reductions on BPI average pain severity) and
- improvement of the general activity and relationships items on the BPI interference subscale.
- There were no new safety concerns related to duloxetine in the study population.
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