title: Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital.
abstract: BACKGROUND
  The lack of specific medicines and labeling recommendations for the pediatric population is a long-standing problem. Using data from an observational study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that off-label status is a risk factor for ADRs.
  
  
  METHODS
  A prospective intensive surveillance was conducted at a pediatric ward of a public teaching hospital. Adverse events to labeled and off-label use were assessed for incidence, severity and predictors. A multivariate Cox proportional hazards regression model used to assess off-label use is a risk factor for ADR occurring.
  
  
  RESULTS
  Off-label and labeled use were responsible for 34 (67%) and 17 (33%) ADRs respectively. Medicines which lacked complete pediatric labeling had the greatest odds for ADRs (9.21% of medicines in this category were implicated, OR 2.84 (95% CI 1.37-7.09). Number of off-label medicines given to patient significantly increased the hazard of an ADR (hazard ratio (HR) 1.28, 95% CI 0.43-3.78, P = 0.002). Number of medicines given also significantly increased the hazard (HR 1.2, 95% CI 0.80-1.71, P < 0.001).
  
  
  CONCLUSIONS
  Use of off-label medicines were more likely to be implicated in an ADR than labeled medicines. This off-label use would be acceptable if evidence of potential benefits outweighs ADRs risk.
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, K.B Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India.
authors.forename: Mohd Masnoon
authors.initials: MM
authors.lastname: Saiyed
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, K.B Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India.
authors.forename: Tarachand
authors.initials: T
authors.lastname: Lalwani
authors.affiliation: Department of Pharmacology, Smt. N.H.L Municipal Medical College, Seth V.S General Hospital, Ellisbridge, Ahmedabad, Gujarat, India.
authors.forename: Devang
authors.initials: D
authors.lastname: Rana
mesh_terms: D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D007223:Infant; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D061214:Patient Safety; D011446:Prospective Studies; D012307:Risk Factors; D062606:Tertiary Care Centers / Q000706:statistics & numerical data*
keywords: Adverse drug reactions; off-label; pediatrics; prescribing