Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.
adverse drug reaction reporting systems
adverse events
disproportionality
off-label use
Journal
Therapeutics and clinical risk management
ISSN: 1176-6336
Titre abrégé: Ther Clin Risk Manag
Pays: New Zealand
ID NLM: 101253281
Informations de publication
Date de publication:
2021
2021
Historique:
received:
26
05
2021
accepted:
10
08
2021
entrez:
30
8
2021
pubmed:
31
8
2021
medline:
31
8
2021
Statut:
epublish
Résumé
The purpose of this study was to investigate the adverse events (AEs) related to the use of off-label drugs. A cross-sectional study was carried out using available data pertaining to off-label drug were sourced from U.S. FDA spontaneous adverse drug reaction reporting database (FAERS) and Korea Adverse Event Reporting System database (KIDS-KD) for the years 2014 to 2018. The number and frequencies of AE cases were calculated. Disproportionality was analyzed using the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM) methods. The reported AEs associated with off-label drug use were more common among older patients compared with younger patients. Gastric nonspecific symptoms and therapeutic procedure (4.16-4.57%) and haemorrage term (4.16-5.29%) were the most common AE symptoms and antithrombotic agents and immunosuppressants were the drugs most commonly reported to cause AEs in FAERS. Secondary term events (43.45-48.62%) including inappropriate schedule of drug administration and medication error were the most common AEs, and immunosuppressants and antipsychotics were the most common AE-related drugs from KIDS-KD. The numbers of reported AEs in new drug categories such as other antineoplastic agents trended to increase from 2014 to 2018 in both datasets. The numbers of reported AEs with off-label drug increased annually. AEs associated with off-label drugs may have a significant impact on older patients. Healthcare experts should be concerned about prescriptions of off-label drugs, especially anticoagulants and newly developed drugs such as immunosuppressants and antineoplastic agents.
Identifiants
pubmed: 34456568
doi: 10.2147/TCRM.S321789
pii: 321789
pmc: PMC8387311
doi:
Types de publication
Journal Article
Langues
eng
Pagination
877-887Informations de copyright
© 2021 Han et al.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest in this work.
Références
Drugs Aging. 2012 Jun 1;29(6):427-34
pubmed: 22642777
World J Pediatr. 2018 Dec;14(6):528-540
pubmed: 30218415
JAMA Intern Med. 2016 Jan;176(1):55-63
pubmed: 26523731
Br J Clin Pharmacol. 2017 Dec;83(12):2615-2625
pubmed: 28779556
Pharmacoepidemiol Drug Saf. 2002 Jan-Feb;11(1):3-10
pubmed: 11998548
Arch Intern Med. 2006 May 8;166(9):1021-6
pubmed: 16682577
Drug Saf. 2021 Jan;44(1):95-105
pubmed: 33354753
ACS Med Chem Lett. 2018 Oct 01;9(10):962-964
pubmed: 30344899
BMJ. 2000 Apr 15;320(7241):1036
pubmed: 10764362
Br J Clin Pharmacol. 1998 Nov;46(5):505-11
pubmed: 9833605
Pediatrics. 2019 Oct;144(4):
pubmed: 31527173
Sci Rep. 2021 Feb 11;11(1):3690
pubmed: 33574396
World Med Health Policy. 2015 Mar;7(1):3-27
pubmed: 25914853
J Okla State Med Assoc. 2018 Oct;111(8):776-783
pubmed: 31379392
Drug Saf. 2007;30(7):617-9
pubmed: 17604415
JAMA. 2002 Jan 16;287(3):337-44
pubmed: 11790213
N Engl J Med. 1999 Feb 11;340(6):477-8; author reply 478-80
pubmed: 9988622
Eur J Clin Pharmacol. 2020 Mar;76(3):449-457
pubmed: 31838548
Int Immunopharmacol. 2019 Nov;76:105866
pubmed: 31491729
MAbs. 2019 Feb/Mar;11(2):219-238
pubmed: 30516432
PLoS One. 2019 Feb 14;14(2):e0212336
pubmed: 30763386
Behav Brain Res. 2021 Apr 23;404:113168
pubmed: 33581145
J Res Pharm Pract. 2015 Apr-Jun;4(2):85-8
pubmed: 25984546
Nat Rev Drug Discov. 2012 Mar 01;11(3):191-200
pubmed: 22378269
Target Oncol. 2020 Aug;15(4):449-466
pubmed: 32725437
Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483-6
pubmed: 11828828
Frontline Gastroenterol. 2014 Jan;5(1):49-57
pubmed: 28839751
Br J Clin Pharmacol. 2016 Dec;82(6):1601-1612
pubmed: 27597136
Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1395-1402
pubmed: 28840629
Comput Biol Chem. 2014 Jun;50:50-9
pubmed: 24534381
Drug Dev Res. 2014 Jun;75(4):231-4
pubmed: 24829189
Pharmacoepidemiol Drug Saf. 2011 Feb;20(2):177-84
pubmed: 21254289
Pharmacoepidemiol Drug Saf. 2012 Apr;21(4):343-51
pubmed: 22318872
Drug Saf. 2009;32(1):19-31
pubmed: 19132802
Eur J Clin Pharmacol. 1998 Jun;54(4):315-21
pubmed: 9696956
Arch Intern Med. 2012 May 28;172(10):781-8
pubmed: 22507695
Int J Med Sci. 2013 Apr 25;10(7):796-803
pubmed: 23794943
Inflamm Bowel Dis. 2013 Feb;19(2):445-56
pubmed: 22573536
J Am Med Inform Assoc. 2016 Mar;23(2):428-34
pubmed: 26209436
BMJ. 2004 Jul 3;329(7456):44-7
pubmed: 15231627
Curr Pharm Des. 2017;23(44):6746-6751
pubmed: 29189127
BMC Clin Pharmacol. 2011 Feb 18;11:2
pubmed: 21332973
Expert Opin Drug Saf. 2014 Jul;13(7):853-7
pubmed: 24918197
J Clin Pharm Ther. 2020 Dec;45(6):1301-1311
pubmed: 32614099
Front Pharmacol. 2020 May 07;11:621
pubmed: 32457620
Clin Pharmacol Ther. 2012 May;91(5):787-95
pubmed: 22472983
Drug Saf. 2012 Jan;35 Suppl 1:29-45
pubmed: 23446784
J Pediatr Pharmacol Ther. 2015 Jul-Aug;20(4):316-28
pubmed: 26380572
Pharmaceuticals (Basel). 2021 May 02;14(5):
pubmed: 34063258
Drug Saf. 2002;25(6):381-92
pubmed: 12071774
BMC Med. 2013 Nov 07;11:238
pubmed: 24229060
Pharmacoepidemiol Drug Saf. 2020 Apr;29(4):396-403
pubmed: 32092786