Educational Paper: Aspects of clinical pharmacology in children- pharmacovigilance and safety

European Journal of Pediatrics

Volumn 172, Issue 5, 2013, Pages 577-580

  Choonara, Imti ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

Adverse drug reaction; Children; Pharmacovigilance

Indexed keywords

CEFTRIAXONE; CHLORAMPHENICOL; NON PRESCRIPTION DRUG; PROPOFOL; SALICYLIC ACID DERIVATIVE; VALPROIC ACID; VIGABATRIN;

CALCIUM PRECIPITATION; CLINICAL PHARMACOLOGY; CUBA; DENMARK; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; EUROPE; GREY BABY SYNDROME; HEALTH PRACTITIONER; HUMAN; LIVER TOXICITY; NEWBORN DISEASE; PATIENT SAFETY; PRECIPITATION; PRIORITY JOURNAL; PROPOFOL INFUSION SYNDROME; REVIEW; REYE SYNDROME; RISK FACTOR; SIDE EFFECT; SPAIN; SWEDEN; UNITED KINGDOM; VISUAL FIELD DEFECT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; HUMANS; PATIENT SAFETY; PHARMACOLOGY, CLINICAL; PHARMACOVIGILANCE;

EID: 84876664992     PISSN: 03406199     EISSN: 14321076     Source Type: Journal    
DOI: 10.1007/s00431-012-1871-9     Document Type: Review

References (39)

1. Aagaard L, Blicher Weber C, Holme Hansen E (2010) Adverse drug reactions in the paediatric population in Denmark. Drug Saf 33:327-339
2. Adefurin A, Sammons H, Jacqz-Aigrain E, Choonara I (2011) Ciprofloxacin safety in paediatrics: a systematic review. Arch Dis Child 96:874-880
3. 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
4. Alkahtani S, Sammons H, Choonara I (2010) Epidemics of acute renal failure in children (diethylene glycol toxicity). Arch Dis Child 95:1062-1064
5. 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
6. Bárzaga Arencibia Z, López Leyva A, Mejías Peña Y, González Reyes AR, Fernández Manzano E, Choonara I (2012) Pharmaco-vigilance in children in Camagüey Province, Cuba. Eur J Clin Pharmacol 68:1079-1084
7. 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
8. Belliard CR, Sibille G (2006) Anaphylactoid shock or precipitation of calcium-ceftriaxone in a premature newborn. A case report. Arch Pediatr 14:199-200
9. Bray RJ (1998) Propofol infusion syndrome in children. Paediatr Anaesth 8:491-499
10. Choonara I (2006) Paediatric pharmacovigilance. Paediatr Perinat Drug Ther 7:50-53
11. Choonara I (2011) Safety of new medicines in young children. Arch Dis Child 96:872-873
12. 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
13. Clavenna A, Bonati M (2009) Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 94:724-728
14. 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
15. Dieppe PA, Ebrahim S, Martin RM, Jüni P (2004) Lessons from the withdrawal of rofecoxib. BMJ 329:867-868
16. Donat JF, Bocchini JA Jr, Gonzalez E, Schwendimann RN (1979) Valproic acid and fatal hepatitis. Neurology 29:273-274
17. Dreifuss FE, Santilli N, Langer DH, Sweeney KP, Moline KA, Menander KB (1987) Valproic acid hepatic fatalities: a retrospective review. Neurology 37:379-385
18. 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
19. Edwards IR, Biriell C (1994) Harmonisation in pharmacovigi-lance. Drug Saf 10:93-102
20. Eke T, Talbot JF, Lawden MC (1997) Severe persistent visual field constriction associated with vigabatrin. BMJ 314:180
21. 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
22. 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
23. 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
24. 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
25. 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
26. Giles H MCc (1965) Encephalopathy and fatty degeneration of the viscera. Lancet 1:1075
27. Medicines Control Agency (1998) Current problems in pharmaco-vigilance. Vigabatrin (Sabril) and visual field defects 24:1
28. 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
29. 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
30. Sammons HM, Gray C, Hudson H et al (2008) Safety in paediatric clinical trials-a 7-year review. Acta Paediatr 97:474-477
31. 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
32. Starko KM, Ray G, Dominguez LB, Stromberg W, Woodall DF (1980) Reye's syndrome and salicylate use. Pediatrics 66:859-864
33. Stiefel G, Besag FMC (2010) Cardiovascular effects of meth-ylphenidate, amphetamines and atomoxetine in the treatment of attention-deficit hyperactivity disorder. Drug Saf 33:821-842
34. Sutherland JM (1959) Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol. AMA J Dis Child 97:761-767
35. Tullus K (2011) Safety concerns of angiotensin II receptor blockers in preschool children. Arch Dis Child 96:881-882
36. 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
37. 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
38. WHO (2008) Ceftriaxone: fatal outcome with calcium-containing solutions. WHO Drug Inf 22:193-194
39. Wieseler B, McGauran N, Kaiser T (2010) Drug studies: a tale of hide and seek. BMJ 341:809-814