Comparison between paediatric and adult suspected adverse drug reactions reported to the European medicines agency: Implications for pharmacovigilance

Pediatric Drugs

Volumn 16, Issue 4, 2014, Pages 309-319

  Blake, Kevin V ^a   Zaccaria, Cosimo ^a   Domergue, Francois ^a   La Mache, Edith ^a   Saint Raymond, Agnes ^a   Hidalgo Simon, Ana ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ATORVASTATIN; BCG VACCINE; CALCIUM CHLORIDE; CARBAMAZEPINE; CHICKENPOX VACCINE; CLOZAPINE; DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS VACCINE; DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; DROSPIRENONE PLUS ETHINYLESTRADIOL; ETANERCEPT; GLUCOSE; IBUPROFEN; INFLIXIMAB; ISOTRETINOIN; LACTATE SODIUM; MAGNESIUM CHLORIDE; MEASLES MUMPS RUBELLA VACCINE; METHYLPHENIDATE; PALIVIZUMAB; PARACETAMOL; PAROXETINE; PNEUMOCOCCUS VACCINE; RECOMBINANT BLOOD CLOTTING FACTOR 8; ROFECOXIB; SODIUM CHLORIDE; UNINDEXED DRUG; VARENICLINE; WART VIRUS VACCINE;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGE DISTRIBUTION; ARTHRALGIA; ARTICLE; BLOOD CLOTTING DISORDER; CHICKENPOX; CHILD; COMPARATIVE STUDY; CONTROLLED STUDY; CONVULSION; CROHN DISEASE; DEEP VEIN THROMBOSIS; DEPRESSION; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG OVERDOSE; DRUG SURVEILLANCE PROGRAM; DRY SKIN; DYSPNEA; EUROPEAN MEDICINES AGENCY; FAINTNESS; FATIGUE; FEMALE; GENDER; GEOGRAPHIC ORIGIN; HEART ATRIUM SEPTUM DEFECT; HEART INFARCTION; HUMAN; INFANT; INFECTION; INFESTATION; INFLAMMATORY BOWEL DISEASE; INJECTION SITE ABSCESS; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE SWELLING; INJURY; LIP DISEASE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; NAUSEA; NEUROLOGIC DISEASE; NEWBORN; PAIN; PATHOLOGICAL CRYING; PERITONITIS; PRESCHOOL CHILD; PRIORITY JOURNAL; PSORIASIS; RESPIRATORY SYNCYTIAL VIRUS INFECTION; RHEUMATOID ARTHRITIS; SCHOOL CHILD; SKIN MANIFESTATION; SUICIDAL IDEATION; TRIACYLGLYCEROL BLOOD LEVEL; ULCERATIVE COLITIS; VIRAL BRONCHIOLITIS; VOMITING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; FACTUAL DATABASE;

ADULT; CHILD; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; HUMANS; PHARMACOVIGILANCE;

EID: 84905562581     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.1007/s40272-014-0076-2     Document Type: Article

References (29)

1. Choonara I. Ethical and safety aspects of clinical trials in neonates. Early Hum Dev. 2009;85(10):S19-20.
2. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, Van den Anker J, On behalf of the European Network for Drug Investigation in Children. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000;320:79-82. (Pubitemid 30173044)
3. European Union Directive 2010/84/EU. Pharmacovigilance. Official Journal of the European Union 31.12.2010. http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. Accessed 14 Apr 2014.
4. Horen B, Montastruc J-L, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002;54(6):665-70. (Pubitemid 36002596)
5. European Parliament and Council of the European Union (27.12.2006, a) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union: L 378/1. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019: en:PDF. Accessed 14 Apr 2014.
6. Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2012/06/WC500129134.pdf. Accessed 14 Apr 2014.
7. Meyboom RH. Adverse reactions to drugs in children, experiences with "spontaneous monitoring" in the Netherlands. Bratisl Lek Listy. 1991;92:554-9.
8. Morales-Olivas FJ, Martinez-Mir I, Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol. 2000;53:1076-80.
9. Kimland E, Rane A, Ufer M, Panagiotidis G. Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharm Drug Saf. 2005;14(493-99):14.
10. Aagaard L, Blicher Weber C, Holme Hansen E. Adverse drug reactions in the paediatric population in Denmark. Drug Saf. 2010;33:327-39.
11. Carleton BC, Smith MA, Gelin MN, Heathcote SC. Paediatric adverse drug reaction reporting: understanding and future directions. Can J Clin Pharmacol. 2007;14:e45-57.
12. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics. 2002;110:e53.
13. European Medicines Agency. EudraVigilance: pharmacovigilance in the European economic area [online]. http://eudravigilance.emea.europa.eu/highres. htm. Accessed 14 Apr 2014.
14. Guideline on good pharmacovigilance practices (GVP) Module VI - Management and reporting of adverse reactions to medicinal products. Available from http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/ 2012/06/WC500129135.pdf. Accessed 14 Apr 2014.
15. The rules governing medicinal products in the European Union. Notice to applicants and regulatory guidelines for medicinal products for human use. Vol. 2 [online]. http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/ eudralex/vol-2/index-en.htm. Accessed 14 Apr 2014.
16. MedDRA Maintenance and Support Services Organization. Introductory Guide to MedDRA Version 14.0. Chantilly, Virginia. March, 2011. http://www.who.int/ medical-devices/innovation/MedDRAintroguide-version14-0-March2011.pdf. Accessed 14 Apr 2014.
17. Copas JR, Hilton FJ. Record linkage: statistical models for matching computer records. J Royal Stat Soc. 1990;153:287-320.
18. Noren GN, Orre R, Bate A, Edwards IR. Duplicate detection in adverse drug surveillance. Data Min Knowl Discov. 2007;14:305-28. (Pubitemid 46582604)
19. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical Investigation of Medicinal Products in the Pediatric Population E11. Current Step 4 version dated 20 July 2000. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/ Guidelines/Efficacy/E11/Step4/E11-Guideline.pdf. Accessed 14 Apr 2014.
20. Star K, Noren GN, Nordin K, Edwards IR. Suspected drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug Saf. 2011;34(5):415-28.
21. Letourneau M, Wells G, Walop W, Duclos P. Improving global monitoring of vaccine safety: a quantitative analysis of adverse event reports in the WHO Adverse Reactions Database. Vaccine. 2008;26(9):1185-94.
22. Volpe JJ. Neurology of the newborn. 5th ed. Philadelphia: Elsevier Health Sciences; 2008. p. p5.
23. Benes F. The development of the pre-frontal cortex, the maturation of neurotransmitter systems and their interactions. In: Nelson CA, Lucian M, editors. Handbook of developmental cognitive neuroscience. MIT press; 2001.
24. Aagaard L, Holme Hansen E. Adverse drug reactions in children reported by European consumers from 2007 to 2011. Int J Clin Pharm. 2014;36:295-302.
25. Star K, Edwards IR. Pharmacovigilance for children's sake. Drug Saf. 2014;37:91-8.
26. European Medicines Agency. Questions and answers on the paediatric use marketing authorisation (PUMA). EMA/753370/2011. London, UK. September 2011. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2011/09/WC500112071. pdf. Accessed 14 Apr 2014.
27. European Medicines Agency. 5-year report to the European Commission EMA/428172/2012. London, U.K. July 2012. http://ec.europa.eu/health/files/ paediatrics/2012-09-pediatric-report-annex1-2-en.pdf. Accessed 14 Apr 2014.
28. European Medicines Agency. Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety reports (ICSRs). EMA/H/20665/04/Final Rev.2. London, UK. October 2010. Available at https://eudravigilance.ema.europa.eu/human/euPoliciesAndDocs03.asp. Accessed 25 May 2014.
29. Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36:75-81.