PMID- 34456568
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220426
IS  - 1176-6336 (Print)
IS  - 1178-203X (Electronic)
IS  - 1176-6336 (Linking)
VI  - 17
DP  - 2021
TI  - Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event 
      Reporting Systems.
PG  - 877-887
LID - 10.2147/TCRM.S321789 [doi]
AB  - PURPOSE: The purpose of this study was to investigate the adverse events (AEs) 
      related to the use of off-label drugs. MATERIALS AND METHODS: 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. RESULTS: 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. 
      CONCLUSION: 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.
CI  - (c) 2021 Han et al.
FAU - Han, Nayoung
AU  - Han N
AD  - Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, 
      Republic of Korea.
AD  - College of Pharmacy, Jeju National University, Jejusi, Jeju Special 
      Self-Governing Province, Republic of Korea.
FAU - Oh, Jung Mi
AU  - Oh JM
AUID- ORCID: 0000-0002-1836-1707
AD  - Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, 
      Republic of Korea.
AD  - College of Pharmacy, Seoul National University, Seoul, Republic of Korea.
FAU - Kim, In-Wha
AU  - Kim IW
AUID- ORCID: 0000-0003-4976-3343
AD  - Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, 
      Republic of Korea.
LA  - eng
PT  - Journal Article
DEP - 20210821
PL  - New Zealand
TA  - Ther Clin Risk Manag
JT  - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC8387311
OTO - NOTNLM
OT  - adverse drug reaction reporting systems
OT  - adverse events
OT  - disproportionality
OT  - off-label use
COIS- The authors report no conflicts of interest in this work.
EDAT- 2021/08/31 06:00
MHDA- 2021/08/31 06:01
PMCR- 2021/08/21
CRDT- 2021/08/30 05:45
PHST- 2021/05/26 00:00 [received]
PHST- 2021/08/10 00:00 [accepted]
PHST- 2021/08/30 05:45 [entrez]
PHST- 2021/08/31 06:00 [pubmed]
PHST- 2021/08/31 06:01 [medline]
PHST- 2021/08/21 00:00 [pmc-release]
AID - 321789 [pii]
AID - 10.2147/TCRM.S321789 [doi]
PST - epublish
SO  - Ther Clin Risk Manag. 2021 Aug 21;17:877-887. doi: 10.2147/TCRM.S321789. 
      eCollection 2021.