Data mining in pharmacovigilance detecting the unexpected: The role of index of suspicion of the reporter

Drug Safety

Volumn 32, Issue 5, 2009, Pages 419-427

  Sundström, Anders ^a,b,d   Hallberg, Pär ^a,c  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

^c UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONTROLLED STUDY; DRUG INFORMATION; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; HUMAN; PRIORITY JOURNAL; SWEDEN; WORLD HEALTH ORGANIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ALGORITHMS; BAYES THEOREM; DATA INTERPRETATION, STATISTICAL; DATABASES, FACTUAL; DRUG MONITORING; DRUG THERAPY; HUMANS; MODELS, STATISTICAL; NEURAL NETWORKS (COMPUTER); SWEDEN;

EID: 65949088372     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200932050-00005     Document Type: Article

References (31)

1. Hauben M, Reich L. Safety related drug-labelling changes: findings from two data mining algorithms. Drug Saf 2004; 27 (10): 735-44
2. van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002 Jan-Feb; 11 (1): 3-10
3. Hauben M, Patadia V, Gerrits C, et al. Data mining in pharmacovigilance: the need for a balanced perspective. Drug Saf 2005; 28 (10): 835-42
4. Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf 2003; 26 (3): 159-86
5. Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol 2004 Feb; 57 (2): 127-34
6. Hippisley-Cox J, Coupland C. Risk of myocardial infarction in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ 2005 Jun 11; 330 (7504): 1366-73
7. Gislason GH, Jacobsen S, Rasmussen JN, et al. Risk of death or reinfarction associated with the use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs after acute myocardial infarction. Circulation 2006 Jun 27; 113 (25): 2906-13
8. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006 Oct 4; 296 (13): 1633-44
9. Solomon SD, McMurray JJ, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005 Mar 17; 352 (11): 1071-80
10. Solomon SD, Pfeffer MA, McMurray JJ, et al. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation 2006 Sep 5; 114 (10): 1028-35
11. Meyboom RH, Egberts AC, Edwards IR, et al. Principles of signal detection in pharmacovigilance. Drug Saf 1997 Jun; 16 (6): 355-65
12. Moore N, Kreft-Jais C, Haramburu F, et al. Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database. Br J Clin Pharmacol 1997 Nov; 44 (5): 513-8
13. Wester K, Jonsson A, Spigset O, et al. Spontaneously reported fatal suspected adverse drug reactions: a 10-year survey from Sweden. Pharmacoepidemiol Drug Saf 2007 Feb; 16 (2): 173-80
14. Bate A. Bayesian confidence propagation neural network. Drug Saf 2007; 30 (7): 623-5
15. Swedish Medical Products Agency [online]. Available from URL: http://www.lakemedelsverket.se [Accessed 2009Mar 3]
16. Medicines and Healthcare products Regulatory Agency [online]. Available from URL: www.mhra.gov.uk [Accessed 2009 Mar 3]
17. ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomized to doxazosin versus chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). JAMA 2000 Apr 19; 283 (15): 1967-75
18. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Diuretic versus alpha-blocker as first-step antihypertensive therapy: final results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Hypertension 2003 Sep; 42 (3): 239-46
19. Strampel W, Emkey R, Civitelli R. Safety considerations with bisphosphonates for the treatment of osteoporosis. Drug Saf 2007; 30 (9): 755-63
20. Brooks JK, Gilson AJ, Sindler AJ, et al. Osteonecrosis of the jaws associated with use of risedronate: report of 2 new cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endodont 2007 Jun; 103 (6): 780-6
21. MHRA. Pharmacovigilance working party public assessment report on neuroleptics and cardiac safety: 2006 [online]. Available from URL: http://www.mhra.gov.uk/home/idcplg?IdcService=SS-GET-PAGE&useSecondary= true&ssDocName = CON019575 [Accessed 2007 Nov 4]
22. Liperoti R, Pedone C, Lapane KL, et al. Venous thromboembolism among elderly patients treated with atypical and conventional antipsychotic agents. Arch Intern Med 2005 Dec 12-26; 165 (22): 2677-82
23. Newcomer JW. Antipsychotic medications: metabolic and cardiovascular risk. J Clin Psychiatry 2007; 68 Suppl. 4: 8-13
24. MHRA. Pharmacovigilance working party public assessment report on antipsychotics and cerebrovascular accident: 2006 [online]. Available from URL: http://www.mhra. gov.uk/home/idcplg?IdcService=SS-GET-PAGE&useSecondary= true&ssDocName=CON019575 [Accessed 2007 Nov 4]
25. US FDA. Antidepressant use in children, adolescents, and adults: 2007 [online]. Available from URL: http://www.fda.gov/cder/drug/antidepressants/ default.htm [Accessed 2007 Nov 4]
26. Giles JJ, Bannigan JG. Teratogenic and developmental effects of lithium. Curr Pharm Des 2006; 12 (12): 1531-41
27. MHRA. Implementation of warnings on suicidal thoughts and behaviour in antidepressants: 2007 [online]. Available from URL: http://www.mhra.gov.uk/ Howweregulate/Medicines/Medicinesregulatorynews/CON2033979 [Accessed 2007 Nov 4]
28. Reith DM, Edmonds L.Assessing the role of drugs in suicidal ideation and suicidality. CNS Drugs 2007; 21 (6): 463-72
29. FDA. Reminyl direct healthcare professional communication, 2005 [online]. Available from URL: www.fda.gov/medwatch/SAFETY/2005/reminylDDLmarch.pdf [Accessed 2007 Nov 4]
30. Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Euro J Clin Pharmacol 1998 Jun; 54 (4): 315-21
31. Edwards IR.What are the real lessons from Vioxx? Drug Saf 2005; 28 (8): 651-8