Adverse drug reactions in children reported by European consumers from 2007 to 2011

International Journal of Clinical Pharmacy

Volumn 36, Issue 2, 2014, Pages 295-302

  Aagaard, Lise ^a   Hansen, Ebba Holme ^b  

^a UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Adverse drug reactions; Children; Consumers; EudraVigilance; Paediatrics; Pharmacovigilance

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ESTRADIOL BENZOATE; ETANERCEPT; ETHINYLESTRADIOL; GESTAGEN; IMMUNOMODULATING AGENT; METHYLPHENIDATE; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE; WART VIRUS VACCINE;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGGRESSION; ARTICLE; BLADDER MALFORMATION; BREAST DISEASE; CARDIOVASCULAR DISEASE; CHILD; CONGENITAL DISORDER; CONNECTIVE TISSUE DISEASE; CONSUMER ATTITUDE; DEPRESSION; DRUG FATALITY; DRUG FEVER; DRUG SURVEILLANCE PROGRAM; EUROPE; FAMILIAL DISEASE; FEBRILE CONVULSION; FEMALE; FOOT MALFORMATION; GENETIC DISORDER; GENITAL MALFORMATION; HEART DISEASE; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HUMAN; INFECTION; INFESTATION; INJECTION SITE ABSCESS; INJECTION SITE EDEMA; INJECTION SITE REACTION; INNER EAR DISEASE; INTOXICATION; KIDNEY DISEASE; LUNG DISEASE; LYMPHATIC SYSTEM DISEASE; MALE; MATERNAL DISEASE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; PATHOLOGICAL CRYING; PATIENT MONITORING; PEDIATRICS; PRIORITY JOURNAL; PULMONARY ASPIRATION; SENSORY DYSFUNCTION; SEX DIFFERENCE; SIDE EFFECT; SKIN DISEASE; SUICIDAL BEHAVIOR; SYSTEMIC THERAPY; THORAX DISEASE; UNSPECIFIED SIDE EFFECT; URINARY TRACT MALFORMATION; UROGENITAL TRACT MALFORMATION; VASCULAR DISEASE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; INFANT; NEWBORN; PRESCHOOL CHILD; TIME;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; TIME FACTORS;

EID: 84899916569     PISSN: 22107703     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11096-013-9874-9     Document Type: Article

References (14)

1. Aagaard L, Christensen A, Hansen EH. Information about adverse drug reactions reported in children: a qualitative review of empirical studies. Br J Clin Pharmacol. 2010;70:481-91.
2. Van Hunsel F, Härmark L, Pal S, Olsson S, van Groothest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35:45-60.
3. De Langen J, Van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands 3 years of experience. Drug Saf. 2008;31:515-54.
4. Medawar C, Herxheimer A. A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxytone. Int J Risk Saf Med. 2004;16:5-19. (Pubitemid 37475764)
5. Aagaard L, Weber CB, Hansen EH. Adverse drug reactions in the paediatric population in Denmark: a retrospective analysis of reports made to the Danish medicines agency from 1998 to 2007. Drug Saf. 2010;33:327-39.
6. Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf. 2009;32:1067-74.
7. Star K, Noren N, Nordin K, Edwards RI. Suspected adverse drug reactions reported for children worldwide: an explorative study using Vigibase. Drug Saf. 2011;34:415-28.
8. Volume 9. Pharmacovigilance: medicinal products for human use and veterinary products. Available at http://ec.europa.eu/health/documents/eudralex/ vol-9/index-en.htm (last accessed 14 July 2013).
9. European Medicines Agency. EudraVigilance access policy for medicines for human use. EMA/759287/2009 corr. Published 23 August 2011.
10. Official journal of the European communities. Regulation (EC) No. 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. L 145/43.
11. MedDRA. Available at http://www.meddramsso.com (last accessed 14 July 2013).
12. WHO collaboration centre for drug statistics methodology (2007) Available at http://www.whocc.no/atc-ddd-index/ (last accessed 14 July 2013).
13. Kricker A, Elliott JW, Forrest JM, McCredie J. Congenital limb reduction deformities and use of oral contraceptives. Am J Obstet Gynecol. 1986;155:1072-8. (Pubitemid 17176683)
14. Li DK, Daling JR, Muelle BA, Hickok DE, Fantel AG, Weiss NS. Oral contraceptive use after conception in relation to the risk of congenital urinary tract anomalies. Teratology. 1995;51:30-6.