Off-Label Topical Calcineurin Inhibitor Use in Children
| Autor: | Simone P. Pinheiro, Angelika D Manthripragada, Chris Worrall, Jeffrey A. Kelman, Thomas E. MaCurdy, David J. Graham, Shahin Saneinejad |
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| Rok vydání: | 2013 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Administration Topical Calcineurin Inhibitors Eczema Off-label use Tacrolimus Dermatitis Atopic Cohort Studies Food and drug administration Young Adult Pimecrolimus Internal medicine Humans Medicine Child Medicaid business.industry Infant Off-Label Use Pharmacoepidemiology Dermatology United States Calcineurin Topical corticosteroid Child Preschool Pediatrics Perinatology and Child Health Female Dermatologic Agents business medicine.drug |
| Zdroj: | Pediatrics. 132:e1327-e1332 |
| ISSN: | 1098-4275 0031-4005 |
| DOI: | 10.1542/peds.2013-0931 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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