Abstract
Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.
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References
Aagaard L, Blicher Weber C, Holme Hansen E (2010) Adverse drug reactions in the paediatric population in Denmark. Drug Saf 33:327–339
Adefurin A, Sammons H, Jacqz-Aigrain E, Choonara I (2011) Ciprofloxacin safety in paediatrics: a systematic review. Arch Dis Child 96:874–880
Aldea A, García Sánchez-Colomer M (2012) Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009. Eur J Clin Pharmacol 68:1329–1338
Alkahtani S, Sammons H, Choonara I (2010) Epidemics of acute renal failure in children (diethylene glycol toxicity). Arch Dis Child 95:1062–1064
Anderson M, Choonara I (2010) A systematic review of safety monitoring and drug toxicity in published randomised controlled trials of antiepileptic drugs in children over a 10-year period. Arch Dis Child 95:731–738
Bárzaga Arencibia Z, López Leyva A, Mejías Peña Y, González Reyes AR, Fernández Manzano E, Choonara I (2012) Pharmacovigilance in children in Camagüey Province, Cuba. Eur J Clin Pharmacol 68:1079–1084
Bárzaga Arencibia Z, Novoa Sotomayer D, Mollinedo C, Choonara I, Fernández Manzano E, López Leyva A (2010) Adverse drug reactions in children in Camagüey Province, Cuba. Arch Dis Child 95:474–477
Belliard CR, Sibille G (2006) Anaphylactoid shock or precipitation of calcium-ceftriaxone in a premature newborn. A case report. Arch Pediatr 14:199–200
Bray RJ (1998) Propofol infusion syndrome in children. Paediatr Anaesth 8:491–499
Choonara I (2006) Paediatric pharmacovigilance. Paediatr Perinat Drug Ther 7:50–53
Choonara I (2011) Safety of new medicines in young children. Arch Dis Child 96:872–873
Clarkson A, Conroy S, Burroughs K, Choonara I (2004) Surveillance for adverse drug reactions in children: a paediatric regional monitoring centre. Paediatr Perinat Drug Ther 6:20–23
Clavenna A, Bonati M (2009) Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 94:724–728
de Vries TW, van Roon EN (2009) Low quality of reporting adverse drug reactions in paediatric randomised controlled trials. Arch Dis Child 95:1023–1026
Dieppe PA, Ebrahim S, Martin RM, Jüni P (2004) Lessons from the withdrawal of rofecoxib. BMJ 329:867–868
Donat JF, Bocchini JA Jr, Gonzalez E, Schwendimann RN (1979) Valproic acid and fatal hepatitis. Neurology 29:273–274
Dreifuss FE, Santilli N, Langer DH, Sweeney KP, Moline KA, Menander KB (1987) Valproic acid hepatic fatalities: a retrospective review. Neurology 37:379–385
Dunn PM (1964) The possible relationship between the maternal administration of sulphamethoxypyridazine and hyperbilirubinaemia in the newborn. J Obstet Gynecol Br Commonwealth 71:128–131
Edwards IR, Biriell C (1994) Harmonisation in pharmacovigilance. Drug Saf 10:93–102
Eke T, Talbot JF, Lawden MC (1997) Severe persistent visual field constriction associated with vigabatrin. BMJ 314:180
Hawcutt DB, Mainie P, Riordan A, Smyth RL, Pirmohamed M (2012) Reported paediatric adverse drug reactions in the UK 2000–2009. Br J Clin Pharmacol 73:437–446
Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M (2001) Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 52:77–83
Impicciatore P, Pandolfini C, Bosetti C, Bonati M (1998) Adverse drug reactions in children: a systematic review of published case reports. Paediatr Perinat Drug Ther:27–32
Kimland E, Rane A, Ufer M, Panagiotidis G (2005) Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharmacoepidemiol Drug Saf 14:493–499
Kunac D, Tatley MV, Grimwood K, Reith DM (2012) Active surveillance of serious adverse drug reactions in New Zealand children. ADC Online First, published May 6
Giles H MCc (1965) Encephalopathy and fatty degeneration of the viscera. Lancet 1:1075
Medicines Control Agency (1998) Current problems in pharmacovigilance. Vigabatrin (Sabril) and visual field defects 24:1
Nor Aripin KNB, Choonara I, Sammons HM (2012) Systematic review of safety in paediatric drug trials published in 2007. Eur J Clin Pharmacol 68:189–194
Parke TJ, Stevens JE, Rice ASC et al (1992) Metabolic acidosis and fatal myocardial failure after propofol infusion in children: five case reports. BMJ 305:613–616
Sammons HM, Gray C, Hudson H et al (2008) Safety in paediatric clinical trials—a 7-year review. Acta Paediatr 97:474–477
Silverman WA, Andersen DH, Blanc WA, Crozier DN (1958) A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens. Pediatrics 18:614–621
Starko KM, Ray G, Dominguez LB, Stromberg W, Woodall DF (1980) Reye’s syndrome and salicylate use. Pediatrics 66:859–864
Stiefel G, Besag FMC (2010) Cardiovascular effects of methylphenidate, amphetamines and atomoxetine in the treatment of attention-deficit hyperactivity disorder. Drug Saf 33:821–842
Sutherland JM (1959) Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol. AMA J Dis Child 97:761–767
Tullus K (2011) Safety concerns of angiotensin II receptor blockers in preschool children. Arch Dis Child 96:881–882
Weiss CF, Glazko AJ, Weston JK (1960) Chloramphenicol in the newborn infant. A physiologic explanation of its toxicity when given in excessive doses. New Engl J Med 262:787–794
Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E (2004) Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet 363:1341–1345
WHO (2008) Ceftriaxone: fatal outcome with calcium-containing solutions. WHO Drug Inf 22:193–194
Wieseler B, McGauran N, Kaiser T (2010) Drug studies: a tale of hide and seek. BMJ 341:809–814
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Choonara, I. Educational Paper: Aspects of clinical pharmacology in children—pharmacovigilance and safety. Eur J Pediatr 172, 577–580 (2013). https://doi.org/10.1007/s00431-012-1871-9
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DOI: https://doi.org/10.1007/s00431-012-1871-9