Is duloxetine (Cymbalta) safe for use in children?

Duloxetine Safety in Children

Duloxetine is FDA-approved and safe for children 7 years and older with generalized anxiety disorder (GAD), but is not approved or recommended for children with major depressive disorder (MDD) or other conditions. 1

FDA-Approved Indications for Children

• Duloxetine is approved for treatment of generalized anxiety disorder (GAD) in children and adolescents aged 7-17 years 1
• Duloxetine demonstrated superiority over placebo in GAD treatment as measured by improvement in the Pediatric Anxiety Rating Scale (PARS) in a 10-week placebo-controlled trial with 272 pediatric patients 1
• Duloxetine is the only SNRI with FDA indication for treatment of any anxiety disorder in children 2

Conditions Where Duloxetine is NOT Approved in Children

• Safety and effectiveness have NOT been established for pediatric patients with major depressive disorder (MDD) 1
• Two 10-week placebo-controlled trials with 800 pediatric patients (7-17 years) failed to demonstrate efficacy of duloxetine for MDD 1
• Safety and effectiveness have NOT been established for diabetic peripheral neuropathic pain or chronic musculoskeletal pain in pediatric patients 1
• Safety and effectiveness have NOT been established for fibromyalgia in patients under 13 years of age 1

Safety Considerations and Monitoring

• Antidepressants increase the risk of suicidal thoughts and behavior in pediatric patients, requiring close monitoring, especially during initial months of treatment or at times of dosage changes 1
• Regular monitoring of weight and growth is necessary in pediatric patients treated with duloxetine 1
• Common adverse effects include nausea, headache, decreased weight, and abdominal pain 1
• Potentially clinically significant elevations in blood pressure may occur, with many cases being transient 3
• Mean increases in pulse (+6.5 beats/min) have been observed in pediatric patients taking duloxetine 4

Pharmacokinetics in Children

• Typical duloxetine clearance in pediatric patients is approximately 42-60% higher than in adults 3, 5
• At a given dose, steady-state duloxetine concentrations in pediatric patients are typically about 30% lower than in adults 5
• Body surface area, dose, and race can affect duloxetine pharmacokinetics, but these effects are not considered clinically meaningful 5
• Age and sex do not significantly affect duloxetine pharmacokinetic parameters 5

Alternative Medications for Children

• For ADHD, stimulants (methylphenidate and amphetamines) are recommended as first-line pharmacological treatment for elementary school-aged children (6-11 years) 6
• Non-stimulant medications like atomoxetine, extended-release guanfacine, and extended-release clonidine are alternative options for ADHD with sufficient evidence 6
• For depression in children, psychotherapeutic treatments should always be used preferentially before considering medication 7
• When antidepressants are needed for children with depression, SSRIs (particularly fluoxetine) should be used first rather than SNRIs like duloxetine 7

Important Cautions

• Duloxetine should be discontinued and not restarted in patients who develop jaundice or other evidence of clinically significant liver dysfunction 2
• Severe skin reactions can occur with duloxetine; it should be discontinued at the first appearance of blisters, peeling rash, or mucosal erosions 2
• Duloxetine may interact with drugs metabolized by CYP1A2 and CYP2D6 2
• Concomitant administration of duloxetine with MAOIs is contraindicated due to increased risk of serotonin syndrome 2