title: Effect of cough and cold medication restriction and label changes on pediatric ingestions reported to United States poison centers.
abstract: OBJECTIVE
  To determine the impact of industry and Food and Drug Administration initiatives implemented to limit the use of over-the-counter (OTC) cough and cold medications in children younger than 6 years of age.
  
  
  METHODS
  This is a retrospective database study of OTC cough and cold medication ingestions reported to US poison centers between 2000 and 2010. Data analyzed from the National Poison Data System included the month and year of ingestion, reason for ingestion, health care utilization, and medical outcome. Ingestion frequencies were stratified by age and reason. Data were divided into pre- and postintervention periods for comparative analysis.
  
  
  RESULTS
  Unintentional ingestions of OTC cough and cold medications decreased 33.4% and therapeutic errors by 46.0%. Health care facility referral declined for unintentional ingestions (28.9% <2 years of age, 19.9% 2-5 years of age, P < .0001) and therapeutic errors in children younger than 2 years of age (59.2%, P < .0001). Moderate and severe adverse outcomes decreased for unintentional ingestions in children younger than 2 years of age by 32.4% and by 21.3% in 2- to 5-year olds, P < .0001.
  
  
  CONCLUSIONS
  The restriction of OTC cough and cold medications has led to a decline in unintentional ingestions, therapeutic errors, health care facility referral, and serious medical outcomes in children younger than 2 years of age. There has also been a decline in ingestions in 2- to 5-year-old children.
authors.affiliation: Department of Emergency Medicine, The George Washington University, Washington, DC; Department of Clinical Pharmacology, Children's National Medical Center, Washington, DC; National Capital Poison Center, Washington, DC. Electronic address: maryannmazer@gmail.com.
authors.forename: Maryann
authors.initials: M
authors.lastname: Mazer-Amirshahi
authors.forename: Nicole
authors.initials: N
authors.lastname: Reid
authors.forename: John
authors.initials: J
authors.lastname: van den Anker
authors.forename: Toby
authors.initials: T
authors.lastname: Litovitz
mesh_terms: D000996:Antitussive Agents / Q000506:poisoning*; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000188:drug therapy*; D016208:Databases, Factual; D004348:Drug Labeling; D005100:Expectorants / Q000506:poisoning; D006633:Histamine Antagonists / Q000506:poisoning; D006801:Humans; D007223:Infant; D014663:Nasal Decongestants / Q000506:poisoning; D004366:Nonprescription Drugs / Q000506:poisoning*; D061214:Patient Safety; D011039:Poison Control Centers; D011041:Poisoning / Q000453:epidemiology*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000996:Antitussive Agents; D005100:Expectorants; D006633:Histamine Antagonists; D014663:Nasal Decongestants; D004366:Nonprescription Drugs
keywords: CHPA; Consumer Healthcare Products Association; FDA; Food and Drug Administration; NPDS; National Poison Data System; OTC; Over-the-counter