Notes
Using WebVDME 4.0 by Lincoln Technologies (Waltham, MA)
References
Trontell A (2004) Expecting the unexpected-drug safety, pharmacovigilance, and the prepared mind. N Engl J Med 351:1385–1387
Stricker BH (2002) Pharmacovigilance: a case of phantom ships and Russian roulette. Ned Tijdsch Geneeskunde 146:1258–1261
Sober AJ, Wick MM (1978) Levodopa therapy and malignant melanoma. JAMA 240:554–555
Fiala KH, Whetteckey J, Manyam BV (2003) Malignant melanoma and levodopa in Parkinson’s disease: causality or coincidence? Parkinsonism Relat Disorders 9:321–327
Williams CS, Woodcock KR (2000) Do ethanol and metonidazole interact to produce a disulfiram-like reaction? Ann Pharmacother 34:255–257
Siple JF, Schneider DC, Wanlass WA, Rosenblatt BK (2000) Levodopa therapy and risk of malignant melanoma. Ann Pharmacother 34:382–385
Kleinhans M, Schmid-Grendelmeier PS, Burg G (1996) Levodopa und malignes melanoma - fallbericht und literaturubersicht ein beitrag zur frage des kausalzusammenhanges zwischen levodopa und der entwicklung eines malignen melanoms. Del Hautgarzt 47:432–437
Toler S, Rodriguez I (2004) Not all sulfa drugs are created equal. Ann Pharmacol 38:2166–2167
Johnson KK, Green DL, Rife JP, Limon L (2005) Sulfonamide cross-reactivity: fact or fiction? Ann Pharmacol 39:290–301
Evans SJ, Waller PC, Davis S (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Safe 10:483–486
Dumouchel W (1999) Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 53(3):170–190
Hauben M, Reich L (2005) Communication of findings in pharmacovigilance: use of term “signal” and the need for precision in its use. Eur J Clin Pharmacol 61(5–6):479–480
Szarfman A, Machado SG, O’Neill RT (2002) Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA’s spontaneous reports database. Drug Saf 25(6):381–392
Knowles S, Shapiro L, Shear NH (2001) Should celecoxib be contraindicated in patients who are allergic to sulfonamides? Revisiting the meaning of ‘sulfa’ allergy. Drug Saf 24:239–247
Walker Be, Patterson A (1974) Induction of cleft palate in mice by tranquilizers and barbiturates. Teratology 10:159–163
Miklovich L, Van den Berg BJ (1976) An evaluation of the teratogenicity of certain antinausea drugs. Am J Obstet Gynecol 125:244–248
Happle (1974) Malignant melanoma and L-dopa. Review of literature on the problem of causal relationship. Fortschr Med 92:1065
Finegold SM (1980) Metronidazole. Ann Intern Med 93:585–587
Dacosta A, Guy JM, Tardy B, Gonthier R, Denis L, Lamaud M, Cerisier A, Verneyre H (1993) Myocardial infarction and nicotine patch: a contributing or causative factor? Eur Heart J 14:1709–1711
Anonymous (1974) Reserpine and breast cancer. Lancet 2:669–671
Behrens-Baumann W, Morawietz A, Thiery J, Creutzfeldt C, Seidel D (1989) Ocular side effects of the lipid-lowering drug simvastatin? A one year follow-up. Lens Eye Toxic Res 6:331–337
Hauben M, Madigan D, Gerrits CM, Walsh L, Van Puijenbroek EP (2005) The role of data mining in pharmacovigilance. Expert Opin Drug Saf 4:929–948
Hauben M, Patadia V, Gerrits C, Walsh L, Reich L (2005) data mining in pharmacovigilance: the need for a balanced perspective. Drug Saf 10:835–842
Bateman DN, Sanders GL, Rawlins MD (1992) Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 34:421–426
Belton KJ (1997) Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 52:423–427
Belton KJ, Lewis SC, Payne S, Rawlins MD, Wood SM (1995) Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 39:223–226
Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G (1997) Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res 35:85–88
Eland IA, Belton KJ, Van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH (1999) Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 48: 23–637
Williams D, Feely J (1999) Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci 168:257–261
De Bruin MI, Van Puijenbroek EP, Egberts AC, Hoes AW, Leufkens HG (2002) Non-sedating antihistamine drugs and cardiac arrhythmias -- biased risk estimates from spontaneous reporting systems? Br J Clin Pharmacol 53:370–374
Chan KA, Hauben M (2005) Signal detection in pharmacovigilance: empirical evaluation of data mining tools. Pharmacoepidemiol Drug Safe 14:597–599
Valenstein PN (1990) Evaluating diagnostic tests with imperfect gold standards. Am J Clin Pathol 93:252–258
Acknowledgement
We would like to thank Barbara J. Stephenson RN, MSC (Epi & Biostats) for her help in critical review of this article.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Hauben, M., Reich, L., Van Puijenbroek, E.P. et al. Data mining in pharmacovigilance: lessons from phantom ships. Eur J Clin Pharmacol 62, 967–970 (2006). https://doi.org/10.1007/s00228-006-0181-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00228-006-0181-4