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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/22/2016
 
Trade Name:  Lyrica
 
Generic Name or Proper Name (*):  pregabalin
 
Indications Studied:  Fibromyalgia
 
Label Changes Summary:  *Safety and efficacy in pediatric patients have not been established. *A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . *The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. *The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  PF Prism CV
 
NNPS:  FALSE
 
Therapeutic Category:  Antidepressant
 
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