MedDRA Literature Article Archive

Below is a list of literature articles (since start of 2004) on MedDRA that have come to the attention of the MSSO. They are provided below for your own reference.

MedDRA Literature Articles	MSSO Response
McLernon, DJ, Bond, CM, Hannaford, PC, Watson,MC, Lee, AJ, Hazell, l and Avery, A. Adverse drug reaction reporting in the UK: a retrospective observational comparison of Yellow Card reports submitted by patients and healthcare professionals. Drug Saf 2010; 33 (9): 775-788
Willemen MJ, Mantel-Teeuwisse AK, Straus SM, Meyboom RH, Egberts TC, Leufkens HG. Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase. Diabetes Care. 2011 Feb;34(2):369-374
Petronijevic, M, Ilic, K, and Suzuki, A. Drug induced hepatotoxicity: data from the Serbian pharmacovigilance database. pharmacoepidemiology and drug safety 2011; 20: 416–423
Star K, Norén GN, Nordin K, Edwards IR. Suspected Adverse Drug Reactions Reported For Children Worldwide: An Exploratory Study Using VigiBase. Drug Saf. 2011 May 1;34(5):415-28
Canhão H, Faustino A, Martins F, Fonseca JE; on behalf Comissão Coordenadora do Registo Nacional de Doentes Reumáticos da Sociedade Portuguesa de Reumatologia:, Sousa E, Pereira da Silva JA, Santos MJ, Canas da Silva J, Melo Gomes JA, Duarte C, Silva JA, Cunha-Miranda L, Teixeira A, Castelão W, Branco JC, Costa JA, Araujo D, Nóvoa T, Figueiredo G, Jesus H, Quintal A, Cravo AR, Sequeira G, Pinto P, André R, Bernardes M, Ventura F, Cunha I, Barcelos A, Nero P, Cruz M. Reuma.pt - the rheumatic diseases portuguese register. ta Reumatol Port. 2011 Jan-Mar;(1):45-56.
Alvarez, Y, Hidalgo, A, Maignen, F and Slattery, J. Validation of Statistical Signal Detection Procedures in EudraVigilance Post-Authorization Data: A Retrospective Evaluation of the Potential for Earlier Signalling. Drug Saf 2010; 33 (6): 475-487
Basaria, S, et.al. Adverse events associated with testosterone administration. NEJM 2010 Jul; 363(2): 109 - 22
Schweizer A, Dejager S, Foley JE, Couturier A, Ligueros-Saylan M, Kothny W. Assessing the cardio-cerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large Phase III type 2 diabetes population. Diabetes Obes Metab. 2010 Jun;12(6):485-94
McCroskery P, Wallace CA, Lovell DJ, Stryker S, Chernyukhin N, Blosch C, Zack DJ. Summary of worldwide pediatric malignancies reported after exposure to etanercept. Pediatr Rheumatol Online J. 2010 Jun 14;8(1):18. [Epub ahead of print]
Feudjo-Tepie, MA, Le Roux, G, Beach, KJ, Bennett, D., and Robinson, NJ. Comorbidities of idiopathic thrombocytopenic purpura: a population-based study. Advances in Hematology 2009, doi:10.1155/2009/963506	MSSO Response
Moore, TJ, Cohen, MR, and Furburg, CD. Quarter Watch: 2008 Quarter 1. Hospital Pharmacy 2009, 44(1): 47 - 56
Merril, GH. The MedDRA paradox. AMIA 2008 Symposium Proceedings 2008, 470 - 474	MSSO Response
Hauben, M and Reich, L. Potential utility of data-mining algorithms for early detection of potentially fatal/disabling adverse drug reactions: a retrospective evaluation. J. Clin. Pharmacol. 2005, 45: 378 - 384
Pearson, RK et al. Influence of the MedDRA® hierarchy on pharmacovigilance data mining results. Int J Med Inform. 2009 Feb 18. [Epub ahead of print]
Lindquist, M. VigiBase, The WHO Global ICSR Database System: Basic Facts. Drug Information Journal 2008; 42: 409 - 419
Czarnecki, A and Voss, S. Safety Signals Using proportional reporting ratios from company and regulatory authority databases. Drug Information Journal 2008; 42: 205–210
Richesson RL, Fung KW, Krischer JP. Heterogeneous but "standard" coding systems for adverse events: Issues in achieving interoperability between apples and oranges. Contemp Clin Trials. 2008 Mar 5 [Epub ahead of print]
DuMouchel, W, Fram, D, Yang, X, Mahmoud, RA, Grogg , AL , Engelhart, L, and Ramaswamy, K. Antipsychotics, glycemic disorders and life-threatening diabetic events: a Bayesian data mining analysis of the FDA Adverse Event Reporting System (1968 - 2004). Annals of Clinical Psychiatry 2008; 20(1): 21 – 31	MSSO Response
Hochberg, AM, Reisinger, SJ, Pearson, RK, O'Hara, DJ, and Hall, K. Using data mining to predict safety actions from FDA Adverse Event Reporting System data. Drug Information Journal 2007; 41(5): 633 - 642
Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. Journal of Clinical Oncology, 2007 Nov 10;25(32):5121-7
Alecu, I, Bousquet, C, Degoulet, P, and Jaulent, M-C. PharmARTS: Terminology Web Services for Drug Safety Coding and Retrieval. MEDINFO 2007, 699 – 704	MSSO Response
Journot, V, Tabuteau, S, Collin, F, Molina, J-M, Chene, G, and Rancinan, C; the ALIZE Study Group. About the necessity to manage events coded with MedDRA prior to statistical analysis: Proposal of a strategy with application to a randomized clinical trial, ANRS 099 ALIZE. Contemporary Clinical Trials 2007 Jun 7; [Epub ahead of print]	MSSO Response
Mozzicato, P. Standardised MedDRA Queries: Their Role in Signal Detection. Drug Safety 2007, 30(7): 617-619
Bo, QY, Xiong, NN, Zou, JD, Jiang, M, liu, F, and Zhao-Wong, A. Internationally agreed medical terminology: Medical Dictionary for Regulatory Activities. Chin J Clin Pharmacol Ther 2007 May; 12(5).
Woodworth T, Furst DE, Alten R, Bingham C, Yocum D, Sloan V, Tsuji W, Stevens R, Fries J, Witter J, Johnson K, Lassere M, Brooks P. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol. 2007 Jun;34(6):1401-14.
Hansen, RA, Gartlehner, G, Powell, GE, and Sadnler, RS. Serious adverse events with Infliximab: analysis of spontaneously reported adverse events. Clin Gastroenterol Hepatol 2007, May 2 [Epub ahead of print]	MSSO Response
Mozzicato, P. MedDRA - Past and Future. RAJ Pharma 2006 17(12): 797 - 805
Starzyk, K., Richards, S., Yee, J., Smith, S.E., and Kingma, W. The long-term international safety experience of imiglucerase therapy for Gaucher disease. Mol Genet Metab 2006 Oct 30; [Epub ahead of print]
Alecu, I. , Bousquet, C., Mougin, F., and Jaulent, M-C. Mapping of the WHO-ART terminology on SNOMED CT to improve grouping of related adverse drug reactions. Stud Health Technol Inform 124: 833 - 838, 2006
Harrison, J. and Zhao-Wong, A. Working with MedDRA to improve data standards. Good Clin Pract J 13(9): 25 - 28, 2006
Zhao-Wong, A.C., Rump, E., Moraleda, T., Mozzicato, P., and Revelle, P. Proposed Terminology Changes to Facilitate the Analysis of MedDRA ® -Coded Data. Drug Information Journal 2006 40 : 291-303
Bailie, G.R., Clark , J.A., Lane, C.E., and Lane, P.L. Hypersensitivitiy reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant 20 : 1443 – 1449, 2005
Brosch, S and Abbinante, F. Using EurdaVigilance for safety reporting. Good Clin Pract J 12 :8, 15 - 18, 2005
van Manen, R. Tuning in to signal detection. Good Clin Pract J 12 :8, 9 - 12, 2005
Toneatti, C., Saidi, Y., Meiffredy, V., Tangre, P., Harel, M., Eliette, V., Dormont, J., and Pierre Alboulker, J. Experience using MedDRA for global events coding in HIV clinical trials. Contemp Clin Trials 2005 Nov 7; [Epub ahead of print]
Chan, K.A. and Hauben, M. Signal detection in pharmacovigilance: empirical evaluation of data mining tools. Pharmacoepidemiology and Drug Safety 2005 14: 597-599
Henegar, C., Bousquet, C., Lillo-LeLouet, A., Degoulet, P. and Jaulent, M.C. Building an ontology of adverse drug reactions for automated signal generation in pharmacovigilance. Comput Biol Med. 2005 Sep 23; [Epub ahead of print]	MSSO Response
Schroeder J.R., Schmittner J.P., Epstein D.H. and Preston K.L. Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: Effects of age, race, and gender. Drug and Alcohol Dependence 2005 80:1 (45-51)	MSSO Response
Thiessard, F., Roux, E., Miremont-Salame, G., Fourrier-Reglat, A., Haramburu, F., Tubert-Bitter, P., and Begaud, B. Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf. 2005;28(8):731-40
Bousquet, C., Henegar, C., Louet, AL, Degoulet, P. and Jaulent, MC. Implementation of automated signal generation in pharmacovigilance using a knowledge-based approach. Int J Med Inform. 2005 Aug;74(7-8):563-571	MSSO Response
Kubler, J., Vonk, R., Beimel, S., Gunselmann, W., Homering, M., Nehrdich, D., Koster, J., Theobald, K., and Voleske, P. Adverse event analysis and MedDRA: Business as usual or challenge? Drug Information Journal 2005 39: 63 - 72
Koo, LC, Clark, JA, Quesenberry, CP, Higenbottam, T, Nyberg, F, Wolf, MK, Steinberg, MH, and Forsythe, BH. National differences in reporting ‘peumonia' and ‘pneumonia interstitial': an analysis of the WHO International Drug Monitoring Database on 15 drugs in nine countries for seven pulmonary conditions. Pharmacoepidemiol Drug Saf 2005, Jan 14 [Epub ahead of print]
Bousquet, C, Lagier, G, Lillo-Le Louet, A, Le Beller, C, Venot, A and Jaulent, MC. Appraisal of the MedDRA Conceptual Structure for Describing and Grouping Adverse Drug Reactions. Drug Safety 2005 28 (1): 19 – 34	MSSO Response
Fescharek, R, Kübler, J, Elsasser, U, Frank, M, Güthlein, P. Medical dictionary for regulatory activities (MedDRA): Data retrieval and presentation. Int J Pharm. Med.2004  18 (5):  259 – 269	MSSO Response
Hauben, M. Application of an empiric Bayesian data mining algorithm to reports of pancreatitis associated with atypical antipsychotics. Pharmacotherapy 2004 Sep; 24 (9):1122-9
Henegar, C, Bousquet, C, Lillo-Le Louet, A, Degoulet, P, Jaulent, M. A knowledge based approach for automated signal detection in Pharmacovigilance. MedInfo 2004: 626 – 630
Marschner, M. Standardization in the Data Management of Clinical Trials Based on MedDRA. Pharm. Ind. 2004 66 (5a): 619 – 622
Campos-Castello, J and Campos-Soler, S. Neuropsychology and epilepsy. Revista de Neurologia 2004 39 (2): 166-177
Klepper MJ. The Periodic Safety Update Report as a Pharmacovigilance Tool. Drug Safety 2004 27 (8): 569-578
Brown EG. Using MedDRA. Implications for Risk Management. Drug Safety 2004 27 (8): 591-602