Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic.
Adverse drug reaction reporting systems
Czech Republic
Direct oral anticoagulants
Pharmacovigilance
Warfarin
Journal
International journal of clinical pharmacy
ISSN: 2210-7711
Titre abrégé: Int J Clin Pharm
Pays: Netherlands
ID NLM: 101554912
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
received:
26
07
2020
accepted:
11
11
2020
pubmed:
28
11
2020
medline:
16
10
2021
entrez:
27
11
2020
Statut:
ppublish
Résumé
Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their safety remains warranted. Objective The aim was to analyze spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic. Setting Retrospective observational pharmacovigilance study. Methods Adverse drug reaction reports were obtained from the State Institute for Drug Control between January 2005 and November 2017. Reports related to warfarin, dabigatran, apixaban, and rivaroxaban received from healthcare professionals and patients were analyzed. Main outcome measure Frequency and nature of adverse drug reactions reported to oral anticoagulants. Results In total, 297 reports containing 672 adverse drug reactions were received; 269 reports were sent by healthcare professionals (85% by physicians). In 65% of all reports, reactions were due to direct oral anticoagulants. A higher total number of adverse drug reactions was associated with direct oral anticoagulants than with warfarin [reporting odds ratio (ROR): 10.76; confidence interval (CI): 8.70-13.32; p < 0.001]. Along with the increasing utilization of direct oral anticoagulants, the reporting rate gradually declined over time, especially for rivaroxaban and apixaban. Fatal outcomes were reported in 7%, mostly for dabigatran. Hemorrhagic reactions were the most frequently reported adverse drug reactions (37% associated with dabigatran, 28% with apixaban, 24% with warfarin, and 23% with rivaroxaban), and compared to warfarin, they were significantly more often associated with direct oral anticoagulants (ROR: 14.36; CI: 9.57-21.54; p < 0.001). Conclusion The number of adverse drug reaction reports related to oral anticoagulants in the Czech Republic was relatively low, compared to other studies, but 96% of the cases were serious. Data from spontaneous adverse drug reactions reporting should be further analyzed in order to obtain additional information on the safety profile of oral anticoagulants.
Identifiants
pubmed: 33245522
doi: 10.1007/s11096-020-01201-2
pii: 10.1007/s11096-020-01201-2
doi:
Substances chimiques
Anticoagulants
0
Warfarin
5Q7ZVV76EI
Dabigatran
I0VM4M70GC
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
948-957Subventions
Organisme : Charles University
ID : SVV 260 551
Informations de copyright
© 2020. Springer Nature Switzerland AG.
Références
McDonald CJ, Kalisch Ellett LM, Barratt JD, Caughey GE. A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm. Drug Saf. 2014;37:1029–35.
doi: 10.1007/s40264-014-0235-y
Monaco L, Biagi C, Conti V, Melis M, Donati M, Venegoni M, et al. Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions. Br J Clin Pharmacol. 2017;83:1532–43.
doi: 10.1111/bcp.13234
Caldeira D, Rodrigues R, Abreu D, Anes AM, Rosa MM, Ferreira JJ. Suspected adverse drug reaction reports with oral anticoagulants in Portugal: a pharmacovigilance study. Expert Opin Drug Saf. 2018;17:339–45.
doi: 10.1080/14740338.2018.1439474
Lippi G, Favaloro EJ. Laboratory monitoring of direct oral anticoagulants (DOACs)—the perfect storm? Ann Transl Med. 2017;5:6.
doi: 10.21037/atm.2017.01.03
World Health Organization. Quality Assurance and Safety of Medicines Team. Safety of medicines: a guide to detecting and reporting adverse drug reactions: why health professionals need to take action. World Health Organization; 2002. https://apps.who.int/iris/handle/10665/67378 . Accessed 11 Oct 2020.
Carrasco-Garrido P, Hernández-Barrera V, Esteban-Hernández J, Jiménez-Trujillo I, Álvaro-Meca A, López de Andrés A, et al. Adverse drug reactions to anticoagulants in Spain: analysis of the Spanish National Hospital Discharge Data (2010–2013). BMJ Open. 2017 Jan;7(1):e013224.
doi: 10.1136/bmjopen-2016-013224
Mirosevic Skvrce N, Macolic Sarinic V, Mucalo I, Krnic D, Bozina N, Tomic S. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study. Croat Med J. 2011;52:604–14.
doi: 10.3325/cmj.2011.52.604
Kopecna E, Descikova V, Vlcek J, Mlada J. Adverse drug reaction reporting in the Czech Republic 2005–2009. Int J Clin Pharm. 2011;33:683–9.
doi: 10.1007/s11096-011-9527-9
McDonald CJ, Kalisch Ellett LM, Barratt JD, Caughey GE. An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran. Pharmacoepidemiol Drug Saf. 2015;24:399–405.
doi: 10.1002/pds.3648
Terayama Y. Evaluation of the efficacy and safety of direct oral anticoagulants in Japanese patients-analysis of pharmaceuticals and medical devices agency data. J Stroke Cerebrovasc Dis. 2017;26(6):1171–81.
doi: 10.1016/j.jstrokecerebrovasdis.2016.12.035
Li R, Curtain C, Bereznicki L, Zaidi STR. Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey. Int J Clin Pharm. 2018;40:878–89.
doi: 10.1007/s11096-018-0700-2
Narum S, Solhaug V, Myhr K, Johansen PW, Brørs O, Kringen MK. Warfarin-associated bleeding events and concomitant use of potentially interacting medicines reported to the Norwegian spontaneous reporting system. Br J Clin Pharmacol. 2011;71:254–62.
doi: 10.1111/j.1365-2125.2010.03827.x
Boudal P, Sommet A, Bagheri H, Pathak A, Montastruc JL. Bleedings induced by oral anticoagulants: a study of adverse drug reactions reported to Midi-Pyrénées PharmacoVigilance Centre between 2003 and 2006. Therapie. 2010;65:567–9.
doi: 10.2515/therapie/2010065
Papastergiou J, Kheir N, Ladova K, Rydant S, De Rango F, Antoniou S, et al. Pharmacists’ confidence when providing pharmaceutical care on anticoagulants, a multinational survey. Int J Clin Pharm. 2017;39:1282–90.
doi: 10.1007/s11096-017-0551-2
Maly J, Dvorackova S, Zimcikova E, Kubena AA, Kolar J, Vlcek J, et al. Patterns in anticoagulant utilization in the Czech Republic during 2007–2017. J Thromb Thrombolysis. 2019;47:305–11.
doi: 10.1007/s11239-019-01806-z
State Institute for Drug Control. Annual reports. http://www.sukl.eu/sukl/publication-activities . Accessed 9 Oct 2020.
Micromedex® Healthcare Series. Thomson Reuters (Healthcare) Inc.; Greenwood Village. http://www.micromedexsolutions.com/ . Accessed 9 Oct 2020.
UpToDate© 2020, Lexicomp® Drug Interactions, Wolters Kluwer. https://www.uptodate.com/drug-interactions/?source=responsive_home#di-druglist . Accessed 9 Oct 2020.
European Medicines Agency © 1995–2019, Eliquis: EPAR—Product Information, Summary of product characteristics. https://www.ema.europa.eu/en/medicines/human/EPAR/eliquis . Accessed 4 October 2020.
European Medicines Agency © 1995–2019, Xarelto: EPAR—Product Information, Summary of product characteristics. https://www.ema.europa.eu/en/medicines/human/EPAR/xarelto . Accessed 4 Oct 2020.
European Medicines Agency © 1995–2019, Pradaxa: EPAR—Product Information, Summary of product characteristics. https://www.ema.europa.eu/en/medicines/human/EPAR/pradaxa#product-information-section . Accessed 4 Oct 2020.
State Institute for Drug Control, Medicinal product database, Summary of Product Characteristics, Warfarin Orion. http://www.sukl.eu/modules/medication/search.php?lang=2 . Accessed 4 Oct 2020.
Eek AK, Strøm BO, Bakkehøi G, Stenberg-Nilsen H. Anticoagulant-associated adverse drug reactions in 2013–15. Tidsskr Nor Laegeforen. 2018. https://doi.org/10.4045/tidsskr.17.0706 .
doi: 10.4045/tidsskr.17.0706
pubmed: 30132616
Fornasier G, Taborelli M, Francescon S, Polesel J, Aliberti M, De Paoli P, et al. Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance. Int J Clin Pharm. 2018;40(4):795–802.
doi: 10.1007/s11096-018-0653-5
Rolfes L, van Hunsel F, Wilkes S, van Grootheest K, van Puijenbroek E. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf. 2015;24:152–8.
doi: 10.1002/pds.3687
Kampichit S, Pratipanawatr T, Jarernsiripornkul N. Confidence and accuracy in identification of adverse drug reactions reported by outpatients. Int J Clin Pharm. 2018;40:1559–67.
doi: 10.1007/s11096-018-0732-7
Raghav S, Reutens D. Neurological sequelae of intrauterine warfarin exposure. Review. J Clin Neurosci. 2007;14(2):99–103.
doi: 10.1016/j.jocn.2006.03.031
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
doi: 10.1056/NEJMoa0905561
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.
doi: 10.1056/NEJMoa1009638
Caughey GE, Kalisch Ellett LM, Barratt JD, Shakib S. Apixaban, concomitant medicines and spontaneous reports of haemorrhagic events. Ther Adv Drug Saf. 2017;8(5):157–64.
doi: 10.1177/2042098616689771
Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92.
doi: 10.1056/NEJMoa1107039
Raschi E, Bianchin M, Ageno W, De Ponti R, De Ponti F. Adverse events associated with the use of direct-acting oral anticoagulants in clinical practice: beyond bleeding complications. Pol Arch Med Wewn. 2016;126:552–61.
pubmed: 27578223
Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36:317–28.
doi: 10.1007/s40264-013-0058-2