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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:  05/03/2018
 
Trade Name:  Lyrica
 
Generic Name or Proper Name (*):  pregabalin
 
Indications Studied:  Adjunctive therapy in the treatment of partial onset seizures (POS) in pediatric patients 4 years to 16 years of age
 
Label Changes Summary:  *Safety and effectiveness as adjunctive treatment for POS in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled trial (n = 295). *Safety and effectiveness in patients less than 4 years of age have not been established. *In the trial in pediatric patients for the treatment of partial onset seizures, somnolence was experienced by 21% of Lyrica-treated patients compared to 14% of placebo-treated patients, and occurred more frequently at higher doses. *The most common adverse reactions with Lyrica in the study were somnolence, weight increased, and increased appetite. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  PF PRISM CV
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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