Duloxetine FDA Approved for Pediatric Fibromyalgia (age 13-17 yr)

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:

  1. Major depressive disorder in adults
  2. Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.
  3. Diabetic peripheral neuropathic pain in adults.
  4. Fibromyalgia in adults and pediatric patients 13 years of age and older.
  5. 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:

  • Nausea
  • Vomiting
  • Decreased Appetite
  • Decreased Weight
  • Headache
  • Somnolence
  • Fatigue
  • 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.

Safety Concerns:

  • There were no new safety concerns related to duloxetine in the study population.

References:

  1. Pediatr Rheumatol Online J. 2019 May 28;17(1):27. PubMed PMID: 31138224; PubMed Central PMCID: PMC6540374. (read article)
  2. Duloxetine package insert. (PDF)

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