메뉴 건너뛰기




Volumn 6, Issue 10, 2011, Pages

Correlation versus causation? pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous adr reporting

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; AMITRIPTYLINE; ANTINUCLEAR ANTIBODY; CELECOXIB; CITRATE POTASSIUM; DICLOFENAC; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIPYRONE; DOXEPIN; ENOXAPARIN; ESTRADIOL; ETORICOXIB; FLUINDOSTATIN; FLUPIRTINE; GABAPENTIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IBUPROFEN; INSULIN; LEVOTHYROXINE; LUMIRACOXIB; MITOCHONDRION ANTIBODY; NON PRESCRIPTION DRUG; NORETHISTERONE; PREGABALIN; PROMETHAZINE; ROFECOXIB; TRAMADOL; ZOLPIDEM;

EID: 80054122083     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0025221     Document Type: Article
Times cited : (34)

References (44)
  • 1
    • 0029066463 scopus 로고
    • Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group
    • Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, et al. (1995) Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA 274: 29-34.
    • (1995) JAMA , vol.274 , pp. 29-34
    • Bates, D.W.1    Cullen, D.J.2    Laird, N.3    Petersen, L.A.4    Small, S.D.5
  • 2
    • 0031012726 scopus 로고    scopus 로고
    • The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group
    • Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, et al. (1997) The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 277: 307-311.
    • (1997) JAMA , vol.277 , pp. 307-311
    • Bates, D.W.1    Spell, N.2    Cullen, D.J.3    Burdick, E.4    Laird, N.5
  • 3
    • 0026244907 scopus 로고
    • Characterization of geriatric drug-related hospital readmissions
    • Bero LA, Lipton HL, Bird JA, (1991) Characterization of geriatric drug-related hospital readmissions. Med Care 29: 989-1003.
    • (1991) Med Care , vol.29 , pp. 989-1003
    • Bero, L.A.1    Lipton, H.L.2    Bird, J.A.3
  • 4
    • 0029984025 scopus 로고    scopus 로고
    • Hospitalisation for adverse events related to drug therapy: incidence, avoidability and costs
    • Dartnell JG, Anderson RP, Chohan V, Galbraith KJ, Lyon ME, et al. (1996) Hospitalisation for adverse events related to drug therapy: incidence, avoidability and costs. Med J Aust 164: 659-662.
    • (1996) Med J Aust , vol.164 , pp. 659-662
    • Dartnell, J.G.1    Anderson, R.P.2    Chohan, V.3    Galbraith, K.J.4    Lyon, M.E.5
  • 5
    • 1542347858 scopus 로고    scopus 로고
    • Actual causes of death in the United States, 2000
    • Mokdad AH, Marks JS, Stroup DF, Gerberding JL, (2004) Actual causes of death in the United States, 2000. JAMA 291: 1238-1245.
    • (2004) JAMA , vol.291 , pp. 1238-1245
    • Mokdad, A.H.1    Marks, J.S.2    Stroup, D.F.3    Gerberding, J.L.4
  • 6
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions
    • Wysowski DK, Swartz L, (2005) Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med 165: 1363-1369.
    • (2005) Arch Intern Med , vol.165 , pp. 1363-1369
    • Wysowski, D.K.1    Swartz, L.2
  • 7
    • 0041342015 scopus 로고    scopus 로고
    • Drug-induced hepatotoxicity
    • Lee WM, (2003) Drug-induced hepatotoxicity. N Engl J Med 349: 474-485.
    • (2003) N Engl J Med , vol.349 , pp. 474-485
    • Lee, W.M.1
  • 8
    • 3042806975 scopus 로고    scopus 로고
    • Detection, verification, and quantification of adverse drug reactions
    • Stricker BH, Psaty BM, (2004) Detection, verification, and quantification of adverse drug reactions. BMJ 329: 44-47.
    • (2004) BMJ , vol.329 , pp. 44-47
    • Stricker, B.H.1    Psaty, B.M.2
  • 9
    • 59949084664 scopus 로고    scopus 로고
    • Using secondary data sources for pharmacoepidemiology and outcomes research
    • Harpe SE, (2009) Using secondary data sources for pharmacoepidemiology and outcomes research. Pharmacotherapy 29: 138-153.
    • (2009) Pharmacotherapy , vol.29 , pp. 138-153
    • Harpe, S.E.1
  • 10
    • 68749110672 scopus 로고    scopus 로고
    • Neural KCNQ (Kv7) channels
    • Brown DA, Passmore GM, (2009) Neural KCNQ (Kv7) channels. Br J Pharmacol 156: 1185-1195.
    • (2009) Br J Pharmacol , vol.156 , pp. 1185-1195
    • Brown, D.A.1    Passmore, G.M.2
  • 11
    • 0032726988 scopus 로고    scopus 로고
    • Flupirtine shows functional NMDA receptor antagonism by enhancing Mg2+ block via activation of voltage independent potassium channels. Rapid communication
    • Kornhuber J, Bleich S, Wiltfang J, Maler M, Parsons CG, (1999) Flupirtine shows functional NMDA receptor antagonism by enhancing Mg2+ block via activation of voltage independent potassium channels. Rapid communication. J Neural Transm 106: 857-867.
    • (1999) J Neural Transm , vol.106 , pp. 857-867
    • Kornhuber, J.1    Bleich, S.2    Wiltfang, J.3    Maler, M.4    Parsons, C.G.5
  • 13
    • 78650447427 scopus 로고    scopus 로고
    • Leberschäden unter Flupirtin (Aus der UAW-Datenbank)
    • Arzneimittelkommission der deutschen Ärzteschaft
    • Arzneimittelkommission der deutschen Ärzteschaft (2007) Leberschäden unter Flupirtin (Aus der UAW-Datenbank). Dtsch Arztebl 104 (46): A 3200.
    • (2007) Dtsch Arztebl , vol.104 , Issue.46
  • 14
    • 0036307464 scopus 로고    scopus 로고
    • Causal association in pharmacovigilance and pharmacoepidemiology: thoughts on the application of the Austin Bradford-Hill criteria
    • Shakir SA, Layton D, (2002) Causal association in pharmacovigilance and pharmacoepidemiology: thoughts on the application of the Austin Bradford-Hill criteria. Drug Saf 25: 467-471.
    • (2002) Drug Saf , vol.25 , pp. 467-471
    • Shakir, S.A.1    Layton, D.2
  • 15
    • 31844443695 scopus 로고
    • The Environment and Disease: Association or Causation?
    • Hill AB, (1965) The Environment and Disease: Association or Causation? Proc R Soc Med 58: 295-300.
    • (1965) Proc R Soc Med , vol.58 , pp. 295-300
    • Hill, A.B.1
  • 16
    • 56549100205 scopus 로고    scopus 로고
    • Causality assessment in hepatotoxicity by drugs and dietary supplements
    • Teschke R, Schwarzenboeck A, Hennermann KH, (2008) Causality assessment in hepatotoxicity by drugs and dietary supplements. Br J Clin Pharmacol 66: 758-766.
    • (2008) Br J Clin Pharmacol , vol.66 , pp. 758-766
    • Teschke, R.1    Schwarzenboeck, A.2    Hennermann, K.H.3
  • 17
    • 0002782575 scopus 로고
    • Screening
    • In: Mayrent SL, editors, Boston, Little, Brown and Company
    • Hennekens CH, Buring JE, (1987) Screening. In: Mayrent SL, editors. Epidemiology in Medicine Boston Little, Brown and Company pp. 327-347.
    • (1987) Epidemiology in Medicine , pp. 327-347
    • Hennekens, C.H.1    Buring, J.E.2
  • 18
    • 0027362542 scopus 로고
    • Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries
    • Danan G, Benichou C, (1993) Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 46: 1323-1330.
    • (1993) J Clin Epidemiol , vol.46 , pp. 1323-1330
    • Danan, G.1    Benichou, C.2
  • 20
    • 0034700782 scopus 로고    scopus 로고
    • The French pharmacovigilance system: structure and missions
    • Welsch M, Alt M, Richard MH, Imbs JL, (2000) The French pharmacovigilance system: structure and missions. Presse Med 29: 102-106.
    • (2000) Presse Med , vol.29 , pp. 102-106
    • Welsch, M.1    Alt, M.2    Richard, M.H.3    Imbs, J.L.4
  • 21
    • 14844365649 scopus 로고    scopus 로고
    • Child overdose: the value of the French pharmacovigilance causality assessment method
    • Rajab M, Lagier G, Eftekhari P, Ginisty S, Bazire A, et al. (2004) Child overdose: the value of the French pharmacovigilance causality assessment method. Therapie 59: 603-606.
    • (2004) Therapie , vol.59 , pp. 603-606
    • Rajab, M.1    Lagier, G.2    Eftekhari, P.3    Ginisty, S.4    Bazire, A.5
  • 22
    • 40849149611 scopus 로고    scopus 로고
    • Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury
    • Garcia-Cortes M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R, et al. (2008) Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury. Aliment Pharmacol Ther 27: 780-789.
    • (2008) Aliment Pharmacol Ther , vol.27 , pp. 780-789
    • Garcia-Cortes, M.1    Lucena, M.I.2    Pachkoria, K.3    Borraz, Y.4    Hidalgo, R.5
  • 24
    • 59749084586 scopus 로고    scopus 로고
    • How common is diclofenac-associated liver injury? Analysis of 17,289 arthritis patients in a long-term prospective clinical trial
    • Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, et al. (2009) How common is diclofenac-associated liver injury? Analysis of 17,289 arthritis patients in a long-term prospective clinical trial. Am J Gastroenterol 104: 356-362.
    • (2009) Am J Gastroenterol , vol.104 , pp. 356-362
    • Laine, L.1    Goldkind, L.2    Curtis, S.P.3    Connors, L.G.4    Yanqiong, Z.5
  • 25
    • 34548168341 scopus 로고    scopus 로고
    • Nonsteroidal anti-inflammatory drug-induced hepatotoxicity
    • Aithal GP, Day CP, (2007) Nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Clin Liver Dis 11: 563-vii.
    • (2007) Clin Liver Dis , vol.11
    • Aithal, G.P.1    Day, C.P.2
  • 26
    • 0023280897 scopus 로고
    • On the adverse reactions and efficacy of long-term treatment with flupirtine: preliminary results of an ongoing twelve-month study with 200 patients suffering from chronic pain states in arthrosis or arthritis
    • Herrmann WM, Kern U, Aigner M, (1987) On the adverse reactions and efficacy of long-term treatment with flupirtine: preliminary results of an ongoing twelve-month study with 200 patients suffering from chronic pain states in arthrosis or arthritis. Postgrad Med J 63 (Suppl 3): 87-103.
    • (1987) Postgrad Med J , vol.63 , Issue.SUPPL. 3 , pp. 87-103
    • Herrmann, W.M.1    Kern, U.2    Aigner, M.3
  • 27
    • 3142715305 scopus 로고    scopus 로고
    • Association between concomitant use of several systemic NSAIDs and an excess risk of adverse drug reaction. A case/non-case study from the French Pharmacovigilance system database
    • Clinard F, Sgro C, Bardou M, Hillon P, Dumas M, et al. (2004) Association between concomitant use of several systemic NSAIDs and an excess risk of adverse drug reaction. A case/non-case study from the French Pharmacovigilance system database. Eur J Clin Pharmacol 60: 279-283.
    • (2004) Eur J Clin Pharmacol , vol.60 , pp. 279-283
    • Clinard, F.1    Sgro, C.2    Bardou, M.3    Hillon, P.4    Dumas, M.5
  • 28
    • 40849119956 scopus 로고    scopus 로고
    • The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO database
    • Bate A, Lindquist M, Edwards IR, (2008) The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO database. Fundam Clin Pharmacol 22: 127-140.
    • (2008) Fundam Clin Pharmacol , vol.22 , pp. 127-140
    • Bate, A.1    Lindquist, M.2    Edwards, I.R.3
  • 29
    • 0043169341 scopus 로고    scopus 로고
    • Analgesic efficacy of flupirtine in primary care of patients with osteoporosis related pain. A multivariate analysis
    • Ringe JD, Miethe D, Pittrow D, Wegscheider K, (2003) Analgesic efficacy of flupirtine in primary care of patients with osteoporosis related pain. A multivariate analysis. Arzneimittelforschung 53: 496-502.
    • (2003) Arzneimittelforschung , vol.53 , pp. 496-502
    • Ringe, J.D.1    Miethe, D.2    Pittrow, D.3    Wegscheider, K.4
  • 30
    • 52949108838 scopus 로고    scopus 로고
    • Combination therapy with flupirtine and opioid: open-label case series in the treatment of neuropathic pain associated with cancer
    • Goodchild CS, Nelson J, Cooke I, Ashby M, Jackson K, (2008) Combination therapy with flupirtine and opioid: open-label case series in the treatment of neuropathic pain associated with cancer. Pain Med 9: 939-949.
    • (2008) Pain Med , vol.9 , pp. 939-949
    • Goodchild, C.S.1    Nelson, J.2    Cooke, I.3    Ashby, M.4    Jackson, K.5
  • 32
    • 62349102834 scopus 로고    scopus 로고
    • Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial*
    • Li C, Ni J, Wang Z, Li M, Gasparic M, et al. (2008) Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial*. Curr Med Res Opin 24: 3523-3530.
    • (2008) Curr Med Res Opin , vol.24 , pp. 3523-3530
    • Li, C.1    Ni, J.2    Wang, Z.3    Li, M.4    Gasparic, M.5
  • 33
    • 38749153991 scopus 로고    scopus 로고
    • Analgesic and muscle tonus normalizing effect of flupirtine retard in chronic back pain. Results of a standardized therapeutic evaluation applying objective methods for measuring pain pressure threshold, pain pressure tolerance and muscle tension
    • Muller-Schwefe GH, Uberall MA, (2008) Analgesic and muscle tonus normalizing effect of flupirtine retard in chronic back pain. Results of a standardized therapeutic evaluation applying objective methods for measuring pain pressure threshold, pain pressure tolerance and muscle tension. MMW Fortschr Med 149 (Suppl 4): 153-161.
    • (2008) MMW Fortschr Med , vol.149 , Issue.SUPPL. 4 , pp. 153-161
    • Muller-Schwefe, G.H.1    Uberall, M.A.2
  • 34
    • 0034094607 scopus 로고    scopus 로고
    • [Acute treatment of episodic childhood tension-type headache with flupirtine and paracetamol - a double-blind crossover-study]
    • Pothmann R, Lobisch M, (2000) [Acute treatment of episodic childhood tension-type headache with flupirtine and paracetamol - a double-blind crossover-study]. Schmerz 14: 1-4.
    • (2000) Schmerz , vol.14 , pp. 1-4
    • Pothmann, R.1    Lobisch, M.2
  • 35
    • 0022016267 scopus 로고
    • Use of flupirtine maleate as an analgesic in patients with liver disease
    • Powell-Jackson P, Williams R, (1985) Use of flupirtine maleate as an analgesic in patients with liver disease. Br J Clin Pract 39: 63-66.
    • (1985) Br J Clin Pract , vol.39 , pp. 63-66
    • Powell-Jackson, P.1    Williams, R.2
  • 36
    • 61449172929 scopus 로고    scopus 로고
    • Investigation of the in vitro metabolism of the analgesic flupirtine
    • Methling K, Reszka P, Lalk M, Vrana O, Scheuch E, et al. (2009) Investigation of the in vitro metabolism of the analgesic flupirtine. Drug Metab Dispos 37: 479-493.
    • (2009) Drug Metab Dispos , vol.37 , pp. 479-493
    • Methling, K.1    Reszka, P.2    Lalk, M.3    Vrana, O.4    Scheuch, E.5
  • 37
    • 0021915908 scopus 로고
    • [Pharmacokinetics and biotransformation of the analgesic flupirtine in humans]
    • Hlavica P, Niebch G, (1985) [Pharmacokinetics and biotransformation of the analgesic flupirtine in humans]. Arzneimittelforschung 35: 67-74.
    • (1985) Arzneimittelforschung , vol.35 , pp. 67-74
    • Hlavica, P.1    Niebch, G.2
  • 38
    • 0026442309 scopus 로고
    • Dose-proportional plasma levels of the analgesic flupirtine maleate in man. Application of a new HPLC assay
    • Niebch G, Borbe HO, Hummel T, Kobal G, (1992) Dose-proportional plasma levels of the analgesic flupirtine maleate in man. Application of a new HPLC assay. Arzneimittelforschung 42: 1343-1345.
    • (1992) Arzneimittelforschung , vol.42 , pp. 1343-1345
    • Niebch, G.1    Borbe, H.O.2    Hummel, T.3    Kobal, G.4
  • 39
    • 0034623311 scopus 로고    scopus 로고
    • Protection of mitochondrial integrity from oxidative stress by the triaminopyridine derivative flupirtine
    • Schluter T, Struy H, Schonfeld P, (2000) Protection of mitochondrial integrity from oxidative stress by the triaminopyridine derivative flupirtine. FEBS Lett 481: 42-46.
    • (2000) FEBS Lett , vol.481 , pp. 42-46
    • Schluter, T.1    Struy, H.2    Schonfeld, P.3
  • 40
    • 0036194357 scopus 로고    scopus 로고
    • Flupirtine blocks apoptosis in batten patient lymphoblasts and in human postmitotic
    • Dhar S, Bitting RL, Rylova SN, Jansen PJ, Lockhart E, et al. (2002) Flupirtine blocks apoptosis in batten patient lymphoblasts and in human postmitotic. Ann Neurol 51: 448-466.
    • (2002) Ann Neurol , vol.51 , pp. 448-466
    • Dhar, S.1    Bitting, R.L.2    Rylova, S.N.3    Jansen, P.J.4    Lockhart, E.5
  • 41
    • 0028670691 scopus 로고
    • The triaminopyridine flupirtine prevents cell death in rat cortical cells induced by N-methyl-D-aspartate and gp120 of HIV-1
    • Perovic S, Schleger C, Pergande G, Iskric S, Ushijima H, et al. (1994) The triaminopyridine flupirtine prevents cell death in rat cortical cells induced by N-methyl-D-aspartate and gp120 of HIV-1. Eur J Pharmacol 288: 27-33.
    • (1994) Eur J Pharmacol , vol.288 , pp. 27-33
    • Perovic, S.1    Schleger, C.2    Pergande, G.3    Iskric, S.4    Ushijima, H.5
  • 42
    • 33745965631 scopus 로고    scopus 로고
    • Retigabine and flupirtine exert neuroprotective actions in organotypic hippocampal cultures
    • Boscia F, Annunziato L, Taglialatela M, (2006) Retigabine and flupirtine exert neuroprotective actions in organotypic hippocampal cultures. Neuropharmacology 51: 283-294.
    • (2006) Neuropharmacology , vol.51 , pp. 283-294
    • Boscia, F.1    Annunziato, L.2    Taglialatela, M.3
  • 43
    • 0037321610 scopus 로고    scopus 로고
    • Attenuation of methamphetamine induced dopaminergic neurotoxicity by flupirtine: microdialysis study on dopamine release and free radical generation
    • Gassen M, Lamensdorf I, Armony T, Finberg JP, Youdim MB, (2003) Attenuation of methamphetamine induced dopaminergic neurotoxicity by flupirtine: microdialysis study on dopamine release and free radical generation. J Neural Transm 110: 171-182.
    • (2003) J Neural Transm , vol.110 , pp. 171-182
    • Gassen, M.1    Lamensdorf, I.2    Armony, T.3    Finberg, J.P.4    Youdim, M.B.5
  • 44
    • 0036124965 scopus 로고    scopus 로고
    • Neuroprotective effect of flupirtine in prion disease
    • Schroder HC, Muller WE, (2002) Neuroprotective effect of flupirtine in prion disease. Drugs Today (Barc) 38: 49-58.
    • (2002) Drugs Today (Barc) , vol.38 , pp. 49-58
    • Schroder, H.C.1    Muller, W.E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.