Paediatric adverse drug reactions reported in Sweden from 1987 to 2001

Pharmacoepidemiology and Drug Safety

Volumn 14, Issue 7, 2005, Pages 493-499

  Kimland, Elin ^a   Rane, Anders ^a   Ufer, Mike ^a,b   Panagiotidis, Georgios ^a  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

Author keywords

Adverse drug reaction; Children; Gender; Outpatients; Paediatric; Pharmacovigilance; Reports; Skin reactions; Vaccines

Indexed keywords

ABSENOR; AMLODIPINE; AMLODIPINE BESYLATE; AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; ASPARAGINASE; BCG VACCINE; BUDESONIDE; CEFACLOR; COTRIMOXAZOLE; DESOGESTREL; DESOLETT; DIAZEPAM; ETHINYLESTRADIOL; GLIBENCLAMIDE; KETOBEMIDONE; LAMOTRIGINE; LORATADINE; PENICILLIN V POTASSIUM; PROPOFOL; TERFENADINE; VACCINE; VALPROIC ACID; WARFARIN;

ABDOMINAL PAIN; ABSCESS; ADOLESCENT; AGRANULOCYTOSIS; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTICLE; BONE DISEASE; BRAIN HEMORRHAGE; CHILD; DRUG ERUPTION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ERYTHEMA MULTIFORME; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; LIVER DYSFUNCTION; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; PANCREATITIS; PEDIATRICS; POPULATION DISTRIBUTION; POPULATION RESEARCH; PRIORITY JOURNAL; PRURITUS; RESPIRATORY TRACT MALFORMATION; SERUM SICKNESS; SKIN MANIFESTATION; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; SUDDEN DEATH; SWEDEN; THROMBOCYTOPENIA; URTICARIA; VASCULAR DISEASE; VOMITING; WORLD HEALTH ORGANIZATION;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; CHILD, PRESCHOOL; DRUG THERAPY; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; OUTPATIENTS; SWEDEN;

EID: 22244443697     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.1121     Document Type: Article

References (35)

1. Leary PM. Adverse drug reactions in children. Drug Saf 1991; 6: 171-182.
2. Bates DW, Spell N, Cullen DJ, et al. The cost of adverse drug events in hospitalized patients: adverse drug event prevention study group. JAMA 1997; 277: 307-311.
3. Lacoste-Roussillon C, Poyanne P, Hamburu F, Miremont G, Bégaud B. Incidence of serious adverse drug reactions in general practice: a prospective study. Clin Pharmacol Therap 2001; 69: 458-462.
4. Easton LK, Colin BC, Brien JE. Frequency and characteristics of hospital admissions associated with drug-related problems in paediatrics. Br J Clin Pharmacol 2004; 57: 611-615.
5. Buajordet I, Wesenberg F, Brors O, Langslet A. Adverse drug events in children during hospitalization and after discharge in a Norwegian University Hospital. Acta Paediatr 2002; 91: 88-94.
6. Easton KL, Chapman CB, Brien JE. Frequency and characteristics of hospital admissions associated with drug-related problems in paediatrics. Br J Clin Pharmacol 2004; 57: 611-615.
7. Martinez-Mir I, Garcia-Lopez M, Palop V, et al. A prospective study of adverse drug reactions as a cause of admission to a paediatric hospital. Br J Clin Pharmacol 1996; 42: 319-324.
8. Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfinic C, Bonati M. Incidence of adverse drug reactions in paediatric in/outpatients: a systematic review and metanalysis of prospective studies. Br J Clin Pharmacol 2001; 52: 77-83.
9. Impicciatore P, Choonara I. Status of new medicines approved by the European Medicines Evaluation Agency reagarding paediatric use. Br J Clin Pharmacol 1999; 48: 15-18.
10. Wilton LV, Pearce G, Mann RD. The use of newly marketed drugs in children and adolescents prescribed in general practice. Pharmacoepidemiol Drug Safe 1999; 8: S37-S45.
11. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries: European network for drug investigation in children. Br Med J 2000; 320: 79-82.
12. Ufer M, Rane A, Karlsson Å, Kimland E, Bergman U. Widespread off-label prescribing of topical but not systemic drugs for 350,000 paediatric outpatients in Stockholm. Eur J Clin Pharmacol 2003; 58: 779-783.
13. Chalumeau M, Treluyer JM, Salanave B, et al. Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child 2000; 83: 502-505.
14. Bucheler R, Schwab M, Mörike K, et al. Off label prescribing to children in primary care in Germany: retrospective cohort study. Br Med J 2002; 324: 1311-1312.
15. Schirm E, Tobi H, de Jong-van den Berg LTW. Unlicensed and off label drug use by children in the community: cross sectional study. Br Med J 2002; 324: 1312-1313.
16. 'T Jong GW, Eland IA, Sturkenboom MCJM, van den Anker JN, Stricker BHCh. Unlicensed and off label presricption of drugs to children: population based cohort study. Br Med J 2002; 324: 1313-1314.
17. Yaffe SJ, Aranda IV. Pediatric Pharmacology: Therapeutic Principles in Practice (2nd edn). WB Saunders Co.: Philadelphia, 1992; 10-21.
18. Horen B, Montastruc JL, Lapeyremestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54: 665-670.
19. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88: 965-968.
20. Wiholm BE, Olsson S, Moore N, Waller P. Spontaneous reporting system outside the US. In Drug Epidemiology and Post-Marketing Surveillance, Strom BL, Velo G (eds). Plenum Publishing Corp.: New York, 1992.
21. Lonnerholm G, Wiholm B-E. Läkemedelsbiverkningar under barnaåren. Barn och Läkemedel. Socialstyrelsen 1980; 3: 7-21 (Article in Swedish).
22. Dalman C, Lonnerholm G, Wiholm B-E. Läkemedelsbiverkningar hos barn. Lakartidningen 1988; 85: 3280-3283.
23. Ufer M, Kimland E, Bergman U. Adverse drug reactions and off-label prescribing for paediatric outpatients a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Safe 2004; 13: 147-152.
24. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002; 110: 1-5.
25. Morales-Olivas FJ, Martines-Mir Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol 2000; 53: 1076-1080.
26. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnoses and management. Lancet 2000; 356: 1255-1259.
27. Läkemedelsverkets klassificeringssystem. MPA, Uppsala Sweden (In Swedish).
28. WHO. International monitoring of adverse reactions to drugs: adverse reaction terminology. WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden, 2003.
29. WHO. Collaborating Centre for Drug Statistics methodology. About the ATC/DDD system [online]. Available from URL; http://www.whocc.no/atcddd/[Acessed 10 Mars 2004].
30. Sanz EJ, Bergman U, Dahlstrom M, Paediatric drug prescribing: a comparison of Tenerife (Canary Island, Spain) and Sweden. Eur J Clin Pharmacol 1989; 37: 65-68.
31. Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reactions in the UK. Arch Dis Child 2002; 87: 462-467.
32. Montastruc JL, Lapeyre-Mestre M, Bagheri H, Fooladi A. Gender differences in adverse drug reactions: analysis of spontaneous reports to a regional pharmacovigilance centre in France. Fundamental Clin Pharmacol 2002; 16: 343-346.
33. Alvarez-Requejo A, Carvajal B, Begaud B, Moride Y, Vega T, Martin Arias LH. Under-reporting of adverse drug reactions: estimate based on a spontaneous reporting scheme and a senile system. Eur J Clin Pharmacol 1998; 54: 483-488.
34. Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. Br Med J 1998; 316: 1295-1298.
35. Smith CC, Bennett PM, Pearce HM, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 1996; 42: 423-429.