Adverse Drug Reactions Reported With Cholinesterase Inhibitors: An Analysis of 16 Years of Individual Case Safety Reports From VigiBase

Annals of Pharmacotherapy

Volumn 49, Issue 11, 2015, Pages 1197-1206

  Kröger, Edeltraut ^a,b   Mouls, Marie ^c   Wilchesky, Machelle ^d,e,f   Berkers, Mieke ^g   Carmichael, Pierre Hugues ^a   van Marum, Rob ^h,i   Souverein, Patrick ^g   Egberts, Toine ^g,j   Laroche, Marie Laure ^c,k  

^a University Laval   (Canada)

^b UNIVERSITÉ LAVAL   (Canada)

^c C H U Dupuytren   (France)

^d MCGILL UNIVERSITY   (Canada)

^e MCGILL UNIVERSITY   (Canada)

^f Donald Berman Maimonides Geriatric Center   (Canada)

^g UTRECHT UNIVERSITY   (Netherlands)

^h JEROEN BOSCH HOSPITAL   (Netherlands)

ⁱ VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^j UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^k UNIVERSITY OF LIMOGES   (France)

more..

Author keywords

adverse drug reactions; Alzheimer s disease; cholinesterase inhibitors; pharmacovigilance; VigiBase

Indexed keywords

CHOLINESTERASE INHIBITOR; DONEPEZIL; GALANTAMINE; PSYCHOTROPIC AGENT; RIVASTIGMINE; INDAN DERIVATIVE; PIPERIDINE DERIVATIVE;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; AGED; AGGRESSION; AGITATION; ALZHEIMER DISEASE; ANTISOCIAL PERSONALITY DISORDER; ANXIETY; APPLICATION SITE REACTION; ARTICLE; ASTHENIA; ASTHMA; ATRIOVENTRICULAR BLOCK; BEHAVIOR DISORDER; BLADDER DISEASE; BRADYCARDIA; BRAIN HEMORRHAGE; BREATHING DISORDER; BRONCHOSPASM; BRONCHUS OBSTRUCTION; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CHOLESTASIS; CHOLESTATIC HEPATITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONFUSION; CONNECTIVE TISSUE DISEASE; CONSCIOUSNESS DISORDER; CONVULSION; COUGHING; DATA ANALYSIS; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DISORIENTATION; DIZZINESS; DRUG FATALITY; DRUG INDUCED DISEASE; DRUG OVERDOSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DYSARTHRIA; DYSKINESIA; DYSPHAGIA; DYSPNEA; EAR DISEASE; EDEMA; EUROPE; EYE DISEASE; FAINTNESS; FATIGUE; FECES INCONTINENCE; FEMALE; FEVER; GAIT DISORDER; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; HALLUCINATION; HEADACHE; HEART ARREST; HEART ARRHYTHMIA; HEART BUNDLE BRANCH BLOCK; HEART DISEASE; HEART MUSCLE CONDUCTION DISTURBANCE; HEART SUPRAVENTRICULAR ARRHYTHMIA; HEART VENTRICLE ARRHYTHMIA; HEMATEMESIS; HEMATOLOGIC DISEASE; HEPATITIS; HEPATOBILIARY DISEASE; HUMAN; HYPERHIDROSIS; HYPERTENSION; HYPERTHERMIA; HYPOTENSION; HYPOTHERMIA; INFECTION; INFESTATION; INJURY; INNER EAR DISEASE; INSOMNIA; INTOXICATION; IRRITABILITY; JAUNDICE; KIDNEY DISEASE; KIDNEY DYSFUNCTION; KIDNEY FAILURE; LANGUAGE DISABILITY; LETHARGY; LIVER DYSFUNCTION; LIVER INJURY; LIVER TOXICITY; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALAISE; MALE; MEDIASTINUM DISEASE; MEDICATION ERROR; MELENA; MENTAL DISEASE; METABOLIC DISORDER; MORTALITY; MOTOR DYSFUNCTION; MUSCLE CONTRACTION; MUSCULOSKELETAL DISEASE; MYOCLONUS; NAUSEA; NEOPLASM; NEUROLOGIC DISEASE; NEUROMUSCULAR DISEASE; NORTH AMERICA; NUTRITIONAL DISORDER; PAIN; PARANOIA; PERCEPTION DISORDER; POLYPHARMACY; PRIORITY JOURNAL; PSYCHOPATHY; RASH; REFERENCE DATABASE; RESPIRATORY DISTRESS; RESPIRATORY FAILURE; RESPIRATORY TRACT DISEASE; SEDATION; SEIZURE; SHOCK; SIDE EFFECT; SKIN DISEASE; SKIN PRURITUS; SLEEP DISORDER; SOMNOLENCE; SPEECH DISORDER; THORAX DISEASE; TREMOR; UNCONSCIOUSNESS; URETHRA DISEASE; URINARY TRACT DISEASE; URINE INCONTINENCE; URINE RETENTION; VASCULAR DISEASE; VIGIBASE; VOMITING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; VERY ELDERLY; WORLD HEALTH ORGANIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; CHOLINESTERASE INHIBITORS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; FEMALE; GALANTAMINE; HUMANS; INDANS; MALE; MEDICATION ERRORS; NORTH AMERICA; PHARMACOVIGILANCE; PIPERIDINES; RIVASTIGMINE; WORLD HEALTH ORGANIZATION;

EID: 84944611043     PISSN: 10600280     EISSN: 15426270     Source Type: Journal    
DOI: 10.1177/1060028015602274     Document Type: Article

References (41)

1. Alzheimer’s Association. 2012 Alzheimer’s disease facts and figures. Alzheimers Dement. 2012;8:131-168.
2. C.P.FerriM.PrinceC.Brayne; for Alzheimer’s Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005;36:2112-2117.
3. J.Birks. Cholinesterase inhibitors for Alzheimer’s disease. Cochrane Database Syst Rev. 2006;(1):CD005593.
4. P.RainaP.SantaguidaA.Ismaila. Effectiveness of cholinesterase inhibitors and memantine for treating dementia: evidence review for a clinical practice guideline. Ann Intern Med. 2008;148:379-397.
5. S.Gauthier. Cholinergic adverse effects of cholinesterase inhibitors in Alzheimer’s disease: epidemiology and management. Drugs Aging. 2001;18:853-862.
6. I.A.LockhartS.A.MitchellS.Kelly. Safety and tolerability of donepezil, rivastigmine and galantamine for patients with Alzheimer’s disease: systematic review of the “real-world” evidence. Dement Geriatr Cogn Disord. 2009;28:389-403.
7. R.A.HansenG.GartlehnerA.P.WebbL.C.MorganC.G.MooreD.E.Jonas. Efficacy and safety of donepezil, galantamine, and rivastigmine for the treatment of Alzheimer’s disease: a systematic review and meta-analysis. Clin Interv Aging. 2008;3:211-225.
8. C.W.RitchieD.AmesT.ClaytonR.Lai. Metaanalysis of randomized trials of the efficacy and safety of donepezil, galantamine, and rivastigmine for the treatment of Alzheimer disease. Am J Geriatr Psychiatry. 2004;12:358-369.
9. E.KrögerR.Van MarumP.SouvereinP.H.CarmichaelT.Egberts. Treatment with rivastigmine or galantamine and risk of urinary incontinence: results from a Dutch database study. Pharmacoepidemiol Drug Saf. 2015;24:276-285.
10. D.H.KimR.T.BrownE.L.DingD.P.KielS.D.Berry. Dementia medications and risk of falls, syncope, and related adverse events: meta-analysis of randomized controlled trials. J Am Geriatr Soc. 2011;59:1019-1031.
11. A.T.IsikE.BozogluM.I.NaharciS.Kilic. Evaluation of the effects of galantamine on cardiac function in elderly patients with Alzheimer’s disease. Am J Geriatr Pharmacother. 2010;8:454-459.
12. L.Y.Park-WyllieM.M.MamdaniP.LiS.S.GillA.LaupacisD.N.Juurlink. Cholinesterase inhibitors and hospitalization for bradycardia: a population-based study. PLoS Med. 2009;6:e1000157.
13. S.S.GillG.M.AndersonH.D.Fischer. Syncope and its consequences in patients with dementia receiving cholinesterase inhibitors: a population-based cohort study. Arch Intern Med. 2009;169:867-873.
14. E.KrögerM.BerkersP.H.CarmichaelP.SouvereinR.Van MarumT.Egberts. Use of rivastigmine or galantamine and risk of adverse cardiac events: a database study from the Netherlands. Am J Geriatr Pharmacother. 2012;10:373-380.
15. P.NordstromD.ReligaA.WimoB.WinbladM.Eriksdotter. The use of cholinesterase inhibitors and the risk of myocardial infarction and death: a nationwide cohort study in subjects with Alzheimer’s disease. Eur Heart J. 2013;34:2585-2591.
16. A.ParienteD.J.SanctussyG.Miremont-SalaméN.MooreF.HaramburuA.Fourrier-Réglat; l’Association Française des Centres Régionaux de Pharmacovigilance (CRPV). Factors associated with serious adverse reactions to cholinesterase inhibitors: a study of spontaneous reporting. CNS Drugs. 2010;24:55-63.
17. S.P.BabaiP.AuricheH.Le-Louet. Comparison of adverse drug reactions with donepezil versus memantine: analysis of the French pharmacovigilance database. Thérapie. 2010;65:255-259.
18. N.TavassoliA.SommetM.Lapeyre-MestreH.BagheriJ.L.Montastruc. Drug interactions with cholinesterase inhibitors: an analysis of the French pharmacovigilance database and a comparison of two national drug formularies (Vidal, British National Formulary). Drug Saf. 2007;30:1063-1071.
19. M.Lindquist. Vigibase, the WHO global ICSR database system: basic facts. Drug Inf J. 2008;42:409-419.
20. World Health Organization. The Uppsala monitoring centre: VigiBase. http://who-umc.org/DynPage.aspx?id=98082&mn1=7347&mn2=7252&mn3=7322&mn4=7326. Accessed April 27, 2015.
21. A.WimoB.WinbladL.Jonsson. The worldwide societal costs of dementia: estimates for 2009. Alzheimers Dement. 2010;6:98-103.
22. Alzheimer’s Disease International. World Alzheimer report 2011: The benefits of early diagnosis and intervention. http://www.alz.co.uk/research/world-report-2011. Accessed April 27, 2015.
23. L.AagaardJ.StrandellL.MelskensP.S.PetersenE.Holme Hansen. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase. Drug Saf. 2012;35:1171-1182.
24. Roots Analysis Private. Alzheimer’s drugs market, 2012-2017. http://www.reportlinker.com/p01364216-summary/Alzheimer-s-Drugs-Market.html. Accessed April 27, 2015.
25. A.ParienteC.HelmerY.MerliereN.MooreA.Fourrier-RéglatJ.F.Dartigues. Prevalence of cholinesterase inhibitors in subjects with dementia in Europe. Pharmacoepidemiol Drug Saf. 2008;17:655-660.
26. L.MuchaS.ShaohungB.CuffelT.McRaeT.L.MarkM.Del Valle. Comparison of cholinesterase inhibitor utilization patterns and associated health care costs in Alzheimer’s disease. J Manag Care Pharm. 2008;14:451-461.
27. J.C.P.Weber. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: K.D.RainsfordG.P.Velo eds. Side Effects of Anti-inflammatory/Analgesic Drugs. New York, NY: Raven Press; 1984:1-7.
28. G.MoulisA.SommetG.DurrieuH.BagheriM.Lapeyre-MestreJ.L.Montastruc; French Association of PharmacoVigilance Centres. Trends of reporting of “serious” vs. “non-serious” adverse drug reactions over time: a study in the French pharmacovigilance database. Br J Clin Pharmacol. 2012;74:201-204.
29. L.MerleM.L.LarocheT.DantoineJ.P.Charmes. Predicting and preventing adverse drug reactions in the very old. Drugs Aging. 2005;22:375-392.
30. US Food and Drug Administration. Exelon patch (rivastigmine) transdermal system. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225994.htm. Accessed April 27, 2015.
31. Health Canada: Santé Canada. Exelon patch (rivastigmine transdermal patch): serious adverse events related to medication errors/misuse. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/14073a-eng.php?_ga=1.102407234.2115486072.1420111412. Accessed April 27, 2015.
32. Agence nationale de sécurité des médicaments et des produits de santé. Dispositifs transdermiques d’Exelon® (Laboratoire Novartis): usage inadapté et erreurs médicamenteuses. Lettre aux professionnels de santé. http://ansm.sante.fr/S-informer/Informations-de-securite-Lettres-aux-professionnels-de-sante/Dispositifs-transdermiques-d-Exelon-R-Laboratoire-Novartis-usage-inadapte-et-erreurs-medicamenteuses-Lettre-aux-professionnels-de-sante. Accessed April 27, 2015.
33. G.AlvaJ.L.Cummings. Relative tolerability of Alzheimer’s disease treatments. Psychiatry (Edgmont). 2008;5:27-36.
34. N.R.DunnG.L.PearceS.A.Shakir. Adverse effects associated with the use of donepezil in general practice in England. J Psychopharmacol. 2000;14:406-408.
35. M.L.LarocheM.C.Perault-PochatI.Ingrand; French Centres of Pharmacovigilance Network. Adverse drug reactions in patients with Alzheimer’s disease and related dementia in France: a national multicentre cross-sectional study. Pharmacoepidemiol Drug Saf. 2013;22:952-960.
36. F.ThiessardE.RouxG.Miremont-Salamé. Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf. 2005;28:731-740.
37. Z.J.WynnJ.L.Cummings. Cholinesterase inhibitor therapies and neuropsychiatric manifestations of Alzheimer’s disease. Dement Geriatr Cogn Disord. 2004;17:100-108.
38. P.CermakovaS.M.FereshtehnejadK.JohnellB.WinbladM.EriksdotterD.Religa. Cardiovascular medication burden in dementia disorders: a nationwide study of 19,743 dementia patients in the Swedish Dementia Registry. Alzheimers Res Ther. 2014;6:34.
39. I.R.EdwardsL.AljM.D.W.TouzaniR.BenkiraneI.R.EdwardsR.Soulaymani. Detecting medication errors in pharmacovigilance databases: capacities and limits. Int J Risk Safety Med. 2007;19:187-194.
40. A.I.BateS.J.Evans. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18:427-436.
41. L.HazellS.A.Shakir. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385-396.