title: Off-label topical calcineurin inhibitor use in children.
abstract: OBJECTIVE
  To assess off-label use of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, in children during periods before and after regulatory action by the US Food and Drug Administration (FDA) in 2005.
  
  
  METHODS
  We identified new pediatric (age <20 years) users of topical tacrolimus or pimecrolimus in US Medicaid from 2001 to 2009, and examined the annual rate of drug use (pre- and postregulatory action) by age. We assessed medical claims for diagnoses consistent with an indication for a TCI, and assessed prescriptions for evidence of first-line atopic dermatitis therapy use before TCI initiation.
  
  
  RESULTS
  There were 57,664 eligible pediatric tacrolimus users and 425,242 eligible pediatric pimecrolimus users at baseline. The rate of TCI use decreased substantially after FDA regulatory action. The proportion of new users younger than 2 years of age significantly decreased for both tacrolimus (36.7% to 22.5%, P < .001) and pimecrolimus (47.0% to 33.7%, P < .001) after regulatory actions. Previous use of topical corticosteroids increased by ≈ 7% for both TCIs from the pre- to postregulatory period. However, after regulatory actions, there was only a small increase in the proportion of tacrolimus or pimecrolimus users with an atopic dermatitis or eczema diagnosis before drug initiation, and high strength use of tacrolimus was unchanged.
  
  
  CONCLUSIONS
  The rate of TCI use in children younger than 2 years of age fell substantially after FDA regulatory action in 2005. Off-label use of TCI as first-line therapy changed little.
authors.affiliation: Center for Observational Research, Amgen Inc, One Amgen Dr, Thousand Oaks, CA 91320. awahnerm@amgen.com.
authors.forename: Angelika D
authors.initials: AD
authors.lastname: Manthripragada
authors.forename: Simone P
authors.initials: SP
authors.lastname: Pinheiro
authors.forename: Thomas E
authors.initials: TE
authors.lastname: MaCurdy
authors.forename: Shahin
authors.initials: S
authors.lastname: Saneinejad
authors.forename: Chris M
authors.initials: CM
authors.lastname: Worrall
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Kelman
authors.forename: David J
authors.initials: DJ
authors.lastname: Graham
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D065095:Calcineurin Inhibitors; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000453:epidemiology; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004485:Eczema / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008484:Medicaid; D056687:Off-Label Use; D016559:Tacrolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus
keywords: off-label drug use; pharmacoepidemiology; topical calcineurin inhibitors