PMID- 34451882
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210831
IS  - 1424-8247 (Print)
IS  - 1424-8247 (Electronic)
IS  - 1424-8247 (Linking)
VI  - 14
IP  - 8
DP  - 2021 Aug 9
TI  - Comparative Safety Profiles of Sedatives Commonly Used in Clinical Practice: A 
      10-Year Nationwide Pharmacovigilance Study in Korea.
LID - 10.3390/ph14080783 [doi]
LID - 783
AB  - This study aims to compare the prevalence and seriousness of adverse events (AEs) 
      among sedatives used in critically ill patients or patients undergoing invasive 
      procedures and to identify factors associated with serious AEs. Retrospective 
      cross-sectional analysis of sedative-related AEs voluntarily reported to the 
      Korea Adverse Event Reporting System from 2008 to 2017 was performed. All AEs 
      were grouped using preferred terms and System Organ Classes per the World Health 
      Organization-Adverse Reaction Terminology. Logistic regression was performed to 
      identify factors associated with serious events. Among 95,188 AEs, including 3132 
      (3.3%) serious events, the most common etiologic sedative was fentanyl (58.8%), 
      followed by pethidine (25.9%). Gastrointestinal disorders (54.2%) were the most 
      frequent AEs. The most common serious AE was heart rate/rhythm disorders (33.1%). 
      Serious AEs were significantly associated with male sex; pediatrics; etiologic 
      sedative with etomidate at the highest risk, followed by dexmedetomidine, 
      ketamine, and propofol; polypharmacy; combined sedative use; and concurrent use 
      of corticosteroids, aspirin, neuromuscular blockers, and antihistamines 
      (reporting odds ratio > 1, p < 0.001 for all). Sedative-induced AEs are most 
      frequently reported with fentanyl, primarily manifesting as gastrointestinal 
      disorders. Etomidate is associated with the highest risk of serious AEs, with the 
      most common serious events being heart rate/rhythm disorders.
FAU - Choi, Yeo-Jin
AU  - Choi YJ
AUID- ORCID: 0000-0002-0635-4374
AD  - Department of Clinical Pharmacy, Graduate School of Clinical Pharmacy, CHA 
      University, Seongnam 13488, Korea.
FAU - Yang, Seung-Won
AU  - Yang SW
AD  - Department of Pharmacy and Yonsei Institute of Pharmaceutical Sciences, College 
      of Pharmacy, Yonsei University, Incheon 21983, Korea.
FAU - Kwack, Won-Gun
AU  - Kwack WG
AD  - Division of Pulmonary, Allergy and Critical Care Medicine, Kyung Hee University 
      Hospital, Seoul 02447, Korea.
FAU - Lee, Jun-Kyu
AU  - Lee JK
AUID- ORCID: 0000-0002-2694-3598
AD  - Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang 10326, 
      Korea.
FAU - Lee, Tae-Hee
AU  - Lee TH
AD  - Institute for Digestive Research, Soonchunhyang University Seoul Hospital, Seoul 
      04401, Korea.
FAU - Jang, Jae-Yong
AU  - Jang JY
AUID- ORCID: 0000-0002-7930-1468
AD  - Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul 
      02447, Korea.
FAU - Chung, Eun-Kyoung
AU  - Chung EK
AUID- ORCID: 0000-0001-9200-2799
AD  - Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul 02447, 
      Korea.
AD  - Department of Pharmacy, Kyung Hee University Hospital at Gangdong, Seoul 05278, 
      Korea.
LA  - eng
GR  - 2020/Dongguk University/
GR  - 2020/Korean Gastrointestinal Endoscopy Research Foundation/
PT  - Journal Article
DEP - 20210809
PL  - Switzerland
TA  - Pharmaceuticals (Basel)
JT  - Pharmaceuticals (Basel, Switzerland)
JID - 101238453
PMC - PMC8399659
OTO - NOTNLM
OT  - KAERS
OT  - adverse events
OT  - drug safety
OT  - patient safety
OT  - pharmacovigilance
OT  - sedatives
COIS- The authors declare no conflict of interest.
EDAT- 2021/08/29 06:00
MHDA- 2021/08/29 06:01
PMCR- 2021/08/09
CRDT- 2021/08/28 01:05
PHST- 2021/07/02 00:00 [received]
PHST- 2021/07/29 00:00 [revised]
PHST- 2021/08/04 00:00 [accepted]
PHST- 2021/08/28 01:05 [entrez]
PHST- 2021/08/29 06:00 [pubmed]
PHST- 2021/08/29 06:01 [medline]
PHST- 2021/08/09 00:00 [pmc-release]
AID - ph14080783 [pii]
AID - pharmaceuticals-14-00783 [pii]
AID - 10.3390/ph14080783 [doi]
PST - epublish
SO  - Pharmaceuticals (Basel). 2021 Aug 9;14(8):783. doi: 10.3390/ph14080783.