title: Off-label use of medicine in pediatrics: focus on gastrointestinal diseases.
abstract: OBJECTIVE
  To provide current information on off-label medication use in pediatric gastroenterology, including a discussion on US legislative efforts to address the issue.
  
  
  RESULTS
  Medications used to treat pediatric gastrointestinal illnesses are frequently prescribed off-label. Acid suppressors, antiemetics, laxatives, and antitumor necrosis factor therapies are types of medications frequently used off-label in the pediatric gastroenterology arena. Pediatric studies conducted under US Federal laws are generating much-needed data on the safety and effectiveness of medications used to treat pediatric patients. Moreover, a new US law, the Food and Drug Administration Safety and Innovation Act, may further the development of pediatric medications in part by requiring pediatric-specific study plans earlier in the overall drug development process. As of today, there still are gaps in our knowledge about these medications, including for the treatment of pediatric gastroenterology diseases.
  
  
  CONCLUSIONS
  Medications are widely used off-label in pediatrics, including medications intended to treat gastrointestinal diseases, such as antitumor necrosis factor and laxatives. Although legislation is helping to generate and make available important information about pediatric medications, most still do not contain pediatric data. Therefore, providers need to understand the potential risks and benefits of prescribing off-label products to pediatric patients.
authors.affiliation: aPediatric and Maternal Health Staff bDivision of Gastroenterology and Inborn Errors Products, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Alyson
authors.initials: A
authors.lastname: Karesh
authors.forename: Juli
authors.initials: J
authors.lastname: Tomaino
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Mulberg
mesh_terms: D002648:Child; D002675:Child, Preschool; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D010372:Pediatrics; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence*; D014481:United States
chemical_list: D005765:Gastrointestinal Agents