The need for pediatric studies of allergy and asthma medications.
For many years, clinicians have accepted the fact that most medications do not have dosing guidelines for children younger than 12 years of age. Recently, there has been a great effort to correct this deficiency. With the introduction of the 1997 Food and Drug Administration Modernization Act, a provision was established to grant additional market exclusivity to pharmaceutical firms that performed the required studies that would lead to improved labeling of medications for children. This effort has resulted in a significant advance for the management of asthma and allergic disorders in children. Several allergy and asthma medications are now approved for use in children as young as 1 year of age, with studies currently being conducted in younger age groups. In this review, we discuss the background for this effort and the continuing impact it will have on the future management of allergy and asthma in children.
Szefler
Stanley J
SJ
National Jewish Medical and Research Center, 1400 Jackson Street, Room J304, Denver, CO 80206, USA. szeflers@njc.org
Whelan
Glenn
G
Gleason
Melanie
M
Spahn
Joseph D
JD
D018926:Anti-Allergic Agents / Q000008:administration & dosage; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy; D007223:Infant; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents