Adverse drug reactions in childhood: A review of prospective studies and safety alerts

Archives of Disease in Childhood

Volumn 94, Issue 9, 2009, Pages 724-728

  Clavenna, Antonio ^a   Bonati, M ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; AMIODARONE; AMPHETAMINE; ANTIDEPRESSANT AGENT; ATOMOXETINE; CEFACLOR; CEFTRIAXONE; CODEINE; DESMOPRESSIN; DEXAMPHETAMINE; DOMPERIDONE; HALOTHANE; HUMAN GROWTH HORMONE; LAMOTRIGINE; LOPINAVIR PLUS RITONAVIR; METOCLOPRAMIDE; NONSTEROID ANTIINFLAMMATORY AGENT; OSELTAMIVIR; OXACILLIN; PALIVIZUMAB; PEMOLINE; PROMETHAZINE; PROPOFOL; RECOMBINANT INTERLEUKIN 11; TOPIRAMATE; VANCOMYCIN; ZONISAMIDE;

ABNORMAL BEHAVIOR; ADVERSE DRUG REACTION; ANAPHYLAXIS; CARDIOVASCULAR DISEASE; CENTRAL NERVOUS SYSTEM; CHILD SAFETY; COMMON COLD; COUGHING; DELIRIUM; DRUG ERUPTION; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG OVERDOSE; DRUG SAFETY; EXTRAPYRAMIDAL SYMPTOM; GASTROINTESTINAL TRACT; HEART ARRHYTHMIA; HOSPITAL ADMISSION; HUMAN; HYPERTHERMIA; HYPONATREMIA; PAPILLEDEMA; PRIORITY JOURNAL; RESPIRATION DEPRESSION; RESPIRATORY TRACT INFECTION; REVIEW; REYE SYNDROME; SEIZURE; SEPTIC SHOCK; SLEEP APNEA SYNDROME; SUICIDAL IDEATION; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CAUSALITY; CHILD; CHILD, PRESCHOOL; DRUG INFORMATION SERVICES; DRUG TOXICITY; HUMANS; INCIDENCE; INFANT; PHARMACEUTICAL PREPARATIONS; PROSPECTIVE STUDIES;

EID: 69249117850     PISSN: 00039888     EISSN: 14682044     Source Type: Journal    
DOI: 10.1136/adc.2008.154377     Document Type: Review

References (41)

1. World Health Organization. Safety of medicines - a guide to detecting and reporting adverse drug reactions - why health professionals need to take action. Geneva: WHO, 2002.
2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279:1200-1205 (Pubitemid 28193431)
3. Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001;52:77-83. (Pubitemid 32862772)
4. Bonati M, Choonara I, Hoppu K, et al. Closing the gap in drug therapy. Lancet 1999;353:1625.
5. Hoppu K. Paediatric clinical pharmacology: at the beginning of a new era. Eur J Clin Pharmacol 2008;64:201-205
6. Choonara I. Improving children's medicines. Arch Dis Child 2006;91:550-551
7. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005;164:552-558 (Pubitemid 41225059)
8. Choonara I, Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Saf 2002;25:1-5. (Pubitemid 34208327)
9. Ghaleb MA, Barber N, Franklin BD, et al. Systematic review of medication errors in pediatric patients. Ann Pharmacother 2006;40:1766-1776 (Pubitemid 44544874)
10. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA 1995;274:29-34.
11. Berkey CS, Hoaglin DC, Mosteller F, et al. A random-effects regression model for meta-analysis. Stat Med 1995;14:395-411.
12. Buajordet I, Wesenberg F, Brors O, et al. Adverse drug events in children during hospitalization and after discharge in a Norwegian university hospital. Acta Paediatr 2002;91:88-94. (Pubitemid 34151227)
13. Holdsworth MT, Fichtl RE, Behta M, et al. Incidence and impact of adverse drug events in pediatric inpatients. Arch Pediatr Adolesc Med 2003;157:60-65 (Pubitemid 36343419)
14. Kaushal R, Goldmann DA, Keohane CA, et al. Adverse drug events in pediatric outpatients. Ambul Pediatr 2007;7:383-389 (Pubitemid 47387112)
15. Zandieh SO, Goldmann DA, Keohane CA, et al. Risk factors in preventable adverse drug events in pediatric outpatients. J Pediatr 2008;152:225-231
16. Weiss J, Krebs S, Hoffmann C, et al. Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection. Pediatrics 2002;110:254-257 (Pubitemid 34833007)
17. Jonville-Bera AP, Giraudeau B, Blanc P, et al. Frequency of adverse drug reactions in children: a prospective study. Br J Clin Pharmacol 2002;53:207-210 (Pubitemid 34264278)
18. Barbosa dos Santos D, Luna Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Saf 2006;15:635-640
19. Neubert A, Dormann H, Weiss J, et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf 2004;27:1059-1067 (Pubitemid 39487067)
20. Neubert A, Dormann H, Weiss J, et al. Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients? Eur J Clin Pharmacol 2006;62:959-965
21. Oshikoya KA, Njokanma OF, Chukwura HA, et al. Adverse drug reactions in Nigerian children. Paediatr Perinat Drug Ther 2007;8:81-88 (Pubitemid 47621487)
22. Lamabadusuriya SP, Sathiadas G. Adverse drug reactions in children requiring hospital admission. Ceylon Med J 2003;48:86-87
23. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002;54:665-670 (Pubitemid 36002596)
24. World Health Organization. Promoting safety of medicines in children. Geneva: WHO, 2007.
25. Impicciatore P, Mohn A, Chiarelli F, et al. Adverse drug reactions to off-label drugs on a paediatric ward: an Italian prospective pilot study. Paediatr Perinat Drug Ther 2002;5:19-24. (Pubitemid 34966671)
26. Turner S, Nunn AJ, Fielding K, et al. Adverse drug reactions to unlicensed and offlabel drugs on paediatric wards: a prospective study. Acta Paediatr 1999;88:965-968 (Pubitemid 29448261)
27. Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 2006;63:332-339 (Pubitemid 43345358)
28. Raz A. Perspectives on the efficacy of antidepressants for child and adolescent depression. PLoS Med 2006;3:e9. (Pubitemid 43200629)
29. Bridge JA, Iyengar S, Salary CB, et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA 2007;297:1683-1696
30. Moreno C, Arango C, Parellada M, et al. Antidepressants in child and adolescent depression: where are the bugs? Acta Psychiatr Scand 2007;115:184-195
31. Usala T, Clavenna A, Zuddas A, et al. Randomised controlled trials of selective serotonin reuptake inhibitors in treating depression in children and adolescents: a systematic review and meta-analysis. Eur Neuropsychopharmacol 2008;18:62-73. (Pubitemid 350213389)
32. Whittington CJ, Kendall T, Fonagy P, et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet 2004;363:1341-1345 (Pubitemid 38529872)
33. Anon. Infant deaths associated with cough and cold medications - two states, 2005. MMWR Morb Mortal Wkly Rep 2007;56:1-4.
34. Food and Drug Administration, Division of Drug Risk Evaluation. Nonprescription Drug Advisory Committee meeting: cold, cough, allergy, bronchodilator, antiasthmatic drug products for over-the-counter human use (memorandum). Rockville, MD: FDA, 2007:29. See http://www.fda.gov/ohrms/ dockets/ac/07/briefing/2007-4323b1-02-FDA.pdf (accessed 25 June 2009).
35. Sharfstein JM, North M, Serwint JR. Over the counter but no longer under the radar - pediatric cough and cold medications. N Engl J Med 2007;357:2321-2324 (Pubitemid 350223385)
36. Smith MB, Feldman W. Over-the-counter cold medications. A critical review of clinical trials between 1950 and 1991. JAMA 1993;269:2258-2263
37. Smith SM, Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev 2008;(1):CD001831. (Pubitemid 351807643)
38. Taverner D, Latte J. Nasal decongestants for the common cold. Cochrane Database Syst Rev 2007;(1):CD001953.
39. Marchetti F, Santuccio C, Gruppo di Lavoro sui Farmaci Pediatrici AIFA. Il trattamento farmacologico del vomito in età pediatrica. Bilancio tra rischi e benefici. Bollettino d'Informazione sui Farmaci 2007;5(Suppl). See http://www. agenziafarmaco.it/allegati/inserto-bif5-2007.pdf (accessed 25 June 2009).
40. Rossignoli A, Clavenna A, Bonati M. Antibiotic prescription and prevalence rate in the outpatient paediatric population: analysis of surveys published during 2000-2005. Eur J Clin Pharmacol 2007;63:1099-1106.
41. Sturkenboom MC, Verhamme KM, Nicolosi A, et al. Drug use in children: cohort study in three European countries. BMJ 2008;337:a2245.