Pediatric drug safety surveillance in FDA-AERS: A description of adverse events from GRiP project

PLoS ONE

Volumn 10, Issue 6, 2015, Pages

  De Bie, Sandra ^a,b   Ferrajolo, Carmen ^a,c   Straus, Sabine M J M ^a,b   Verhamme, Katia M C ^a   Bonhoeffer, Jan ^d,e   Wong, Ian C K ^f   Sturkenboom, Miriam C J M ^a   Giaquinto, Carlo ^g   Gazarian, Madlen ^h   Ceci, Adriana ⁱ   Weereasuriya, Krisanta ^j   Hirschfeld, Steven ^k   Saint Raymond, Agnes ^l   Nakamura, Hidefumi ^m   Sharland, Mike ⁿ   Offringa, Martin ^o   Hoppu, Kalle ^p  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c SECOND UNIVERSITY OF NAPLES   (Italy)

^d Brighton Collaboration Foundation   (Switzerland)

^e UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^f UNIVERSITY OF HONG KONG   (Hong Kong)

^g UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^h UNIVERSITY OF NEW SOUTH WALES   (Australia)

ⁱ Department of Biostatistics   (Italy)

^j WORLD HEALTH ORGANIZATION   (Switzerland)

^k EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^l EUROPEAN MEDICINES AGENCY   (United Kingdom)

^m NATIONAL CENTER FOR CHILD HEALTH AND DEVELOPMENT   (Japan)

ⁿ ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^o ACADEMIC MEDICAL CENTER   (Netherlands)

^p HOSPITAL DISTRICT OF HELSINKI AND UUSIMAA   (Finland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; AMPICILLIN; ARIPIPRAZOLE; ATOMOXETINE; CHOLINE SALICYLATE; DOPAMINE; FLUTICASONE; FUROSEMIDE; GENTAMICIN; HUMAN GROWTH HORMONE; IBUPROFEN; INFLIXIMAB; INSULIN; ISOTRETINOIN; LAMIVUDINE; LAMOTRIGINE; METHOTREXATE; METHYLPHENIDATE; MITOXANTRONE; MONTELUKAST; NITRIC OXIDE; PALIVIZUMAB; PARACETAMOL; RANITIDINE; SALBUTAMOL; UNINDEXED DRUG; VALPROIC ACID; VITAMIN; ZIDOVUDINE; DRUG;

ADOLESCENT; ADULT; ADVERSE OUTCOME; ARTICLE; BEHAVIOR DISORDER; CHILD; CONGENITAL DISORDER; CONTROLLED STUDY; CONVULSION; DRUG EXPOSURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FAMILIAL DISEASE; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; GENETIC DISORDER; GROUPS BY AGE; HEADACHE; HUMAN; INFANT; INFECTION; INFESTATION; INFLAMMATORY BOWEL DISEASE; MAJOR CLINICAL STUDY; MALE; NEWBORN; OUTCOME ASSESSMENT; PREMATURITY; PRESCHOOL CHILD; SCHOOL CHILD; TREATMENT DURATION; UNITED STATES; UNSPECIFIED SIDE EFFECT; VOMITING; CLASSIFICATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FACTUAL DATABASE;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; CHILD, PRESCHOOL; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; INFANT; INFANT, NEWBORN; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84939236006     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0130399     Document Type: Article

References (36)

1. Breslow LH. The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing. Harvard J Legis. 2003; 40(1):133-93. Epub 2006/04/06. PMID: 16594116
2. Dunne J. The European Regulation on medicines for paediatric use. Paediatr Respir Rev. 2007; 8 (2):177-83. PMID: 17574163
3. Jacqz-Aigrain E. Drug policy in Europe Research and funding in neonates: current challenges, future perspectives, new opportunities. Early Hum Dev. 2011; 87 Suppl 1:S27-30. Epub 2011/01/29. doi: 10. 1016/j.earlhumdev.2011.01.007 PMID: 21269785
4. GRiP. Global Research in Paediatrics-Network of Excellence (GRiP). 2011 [2012 Sep 27]; Available: http://grip-network.org/.
5. Star K. Detecting unexpected adverse drug reactions in children. Paediatr Drugs. 2011; 13(2):71-3. doi: 10.2165/11589100-000000000-00000 PMID: 21351806
6. Alvarez Y, Hidalgo A, Maignen F, Slattery J. Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling. Drug safety. 2010; 33(6):475-87. doi: 10.2165/11534410-000000000-00000 PMID: 20486730
7. Lindquist M. VigiBase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal. 2008; 42:409-19.
8. Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT. An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group. Vaccine. 1999; 17 (22):2908-17. Epub 1999/08/07. PMID: 10438063
9. Hammond IW, Gibbs TG, Seifert HA, Rich DS. Database size and power to detect safety signals in pharmacovigilance. Expert opinion on drug safety. 2007; 6(6):713-21. PMID: 17967160
10. Adverse Event Reporting System (AERS). [updated 27-9-20122012 Sep 27]; Available: http://www.fda. gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm.
11. Vaccine Adverse Events Reporting System (VAERS) Data. [updated 27-9-20122012 Sep 27]; Available: http://vaers.hhs.gov/data/data.
12. EudraVigilance access policy for medicines for human use [2012 Sep 27]; Available: http://www.ema. europa.eu/docs/en-GB/document-library/Other/2011/07/WC500108538.pdf.
13. UMC access policy for The WHO Global Individual Case Safety Report database, VigiBase. [2012 Sep 27]; Available: http://www.who-umc.org/DynPage.aspx?id=105196&mn1=7347&mn2=7489&mn3= 7248&newsid=10830.
14. Star K, Noren GN, Nordin K, Edwards IR. Suspected Adverse Drug Reactions Reported For Children Worldwide: An Exploratory Study Using VigiBase. Drug safety. 2011; 34(5):415-28. doi: 10.2165/ 11587540-000000000-00000 PMID: 21513364
15. Johann-Liang R, Wyeth J, Chen M, Cope JU. Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007. Pharmacoepidemiology and drug safety. 2009; 18(1):24-7. Epub 2008/11/15. doi: 10.1002/pds.1679 PMID: 19009550
16. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics. 2002; 110(5):e53. PMID: 12415059
17. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med. 2007; 167(16):1752-9. Epub 2007/09/12. PMID: 17846394
18. Drug Information Online. [2012 Sep 27]; Available: http://www.drugs.com/.
19. Pharmacy Codes. [2012 Sep 27]; Available: http://pharmacycode.com.
20. Medicines.org.uk. [2012 Sep 24]; Available: http://www.medicines.org.uk/emc/.
21. WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment. [cited 27-9-2012]; Available: http://www.whocc.no/.
22. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. Clinical Investigation Of Medicinal Products In The Pediatric Population E11. 2000 [27-9-2012]; Available: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/ Efficacy/E11/Step4/E11-Guideline.pdf.
23. Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA Adverse Event Reporting System. International journal of medical sciences. 2013; 10(7):796-803. Epub 2013/ 06/26. doi: 10.7150/ijms.6048 PMID: 23794943
24. WHO. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. The Extend of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life Threatening Conditions: E1. 1994.
25. Ferrajolo C, Capuano A, Trifiro G, Moretti U, Rossi F, Santuccio C. Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001-2012. Expert opinion on drug safety. 2014; 13 Suppl 1:S9-20. Epub 2014/08/30. doi: 10.1517/14740338. 2014.939581 PMID: 25171155
26. Subbarao P, Mandhane PJ, Sears MR. Asthma: epidemiology, etiology and risk factors. CMAJ: Canadian Medical Association journal = journal de l'Association medicale canadienne. 2009;181(9):E181-90. Epub 2009/09/16.
27. Tekgul S, Riedmiller H, Hoebeke P, Kocvara R, Nijman RJ, Radmayr C, et al. EAU guidelines on vesicoureteral reflux in children. European urology. 2012; 62(3):534-42. Epub 2012/06/16. doi: 10.1016/j. eururo.2012.05.059 PMID: 22698573
28. Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. The American journal of psychiatry. 2007; 164 (6):942-8. Epub 2007/06/02. PMID: 17541055
29. Sturkenboom MC, Verhamme KM, Nicolosi A, Murray ML, Neubert A, Caudri D, et al. Drug use in children: cohort study in three European countries. Bmj. 2008; 337:a2245. doi: 10.1136/bmj.a2245 PMID: 19029175
30. Chai G, Governale L, McMahon AW, Trinidad JP, Staffa J, Murphy D. Trends of outpatient prescription drug utilization in US children, 2002-2010. Pediatrics. 2012; 130(1):23-31. Epub 2012/06/20. doi: 10. 1542/peds.2011-2879 PMID: 22711728
31. van Hunsel F, Harmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug safety. 2012; 35(1):45-60. Epub 2011/12/14. doi: 10. 2165/11594320-000000000-00000 PMID: 22149419
32. Zito JM, Safer DJ, DosReis S, Gardner JF, Magder L, Soeken K, et al. Psychotropic practice patterns for youth: a 10-year perspective. Arch Pediatr Adolesc Med. 2003; 157(1):17-25. Epub 2003/01/09. PMID: 12517190
33. de Bie S, Verhamme KM, Straus SM, Stricker BH, Sturkenboom MC. Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection. Drug safety. 2012; 35(4):335-46. Epub 2012/03/23. doi: 10.2165/11598120-000000000-00000 PMID: 22435344
34. VIII CWG. Practical Aspects of Signal Detection in Pharmacovigilance. Report of CIOMS Working Group VIII. Geneva: CIOMS, 2010.
35. Noren GN, Orre R, Bate A, Edwards IR. Duplicate detection in adverse drug reaction surveillance. Data Mining and Knowledge Discovery. 2007; 14(3):305-28.
36. Hauben M, Reich L, DeMicco J, Kim K. 'Extreme duplication' in the US FDA Adverse Events Reporting System database. Drug safety. 2007; 30(6):551-4. Epub 2007/06/01. PMID: 17536881