US Perspective on Off‐label Use in Pediatrics

Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children

“…Off-label prescribing in pediatric health care tends to be higher among pediatric medicine subspecialists, and the percentage of off-label gastrointestinal medications may be as high as 80% in the pediatric outpatient setting. The issues of off-label medication use in pediatric gastroenterology has been published recently, stressing the need for approved products to treat inflammatory bowel disease, infant gastroesophageal reflux, and eosinophilic esophagitis 11, 12, 13. “Most patients hospitalized at tertiary care pediatric institutions receive at least medication outside the terms of the FDA product license.” 14 Off-label drug use was particularly noticeable with drugs targeting the central nervous system and drugs related to fluids, nutrients, and gastrointestinal tract.…”