Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital

The International Journal of Risk & Safety in Medicine
Mohd Masnoon SaiyedDevang Rana

Abstract

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. 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. 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). Use of off-label medicines were more likely to be implicated in an ADR than labeled medicines. This off-label use would be ...Continue Reading

Associated Clinical Trials

Sep 10, 2015·Kristine Svinning Valeur

Citations

Sep 14, 2017·Paediatric Drugs·Paolo A TomasiAgnes Saint-Raymond
Sep 8, 2018·Journal of Korean Medical Science·Ji-Hyun LeeHee-Soo Kim
Jan 12, 2019·Clinical Journal of the American Society of Nephrology : CJASN·Lavanya BathiniAmit X Garg
Feb 7, 2017·Journal of Clinical Pharmacy and Therapeutics·M M SaiyedL Chew
Oct 14, 2020·Journal of Evidence-based Medicine·Sara Raquel Almeida AndradeWellington Barros da Silva
May 25, 2021·Frontiers in Pharmacology·Kristopher Amaro-HoseyAntònia Agustí
Jun 23, 2020·Journal of Pain and Symptom Management·Isabel García-LópezRicardo Martino-Alba

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