PMID- 37837355
OWN - NLM
STAT- MEDLINE
DCOM- 20240308
LR  - 20240308
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 3
DP  - 2024 Mar
TI  - Data mining and analysis of the adverse events derived signals of 4 
      gadolinium-based contrast agents based on the US Food and drug administration 
      adverse event reporting system.
PG  - 339-352
LID - 10.1080/14740338.2023.2271834 [doi]
AB  - BACKGROUND: To detect and analyze risk signals of the drug-related adverse events 
      (AEs) of 4 gadolinium-based contrast agents (GBCAs) (gadopentetate dimeglumine 
      (Gd-DTPA), gadobenate dimeglumine (Gd-BOPTA), gadoteridol (Gd-HP-DO3A), and 
      gadobutrol (Gd-BT-DO3A)) according to the US Food and Drug Administration Adverse 
      Event Reporting System (FAERS) database and ensure the clinical safety. RESEARCH 
      DESIGN AND METHODS: The AEs that are associated with the 4 GBCAs were collected 
      from the FAERS database from 2004Q1 to 2022Q3. The risk signals were mined using 
      reporting odds ratio (ROR) and proportional reporting ratio (PRR). RESULTS: 424 
      risk signals were excavated, in which 151 risk signals were associated with 
      Gd-DTPA, 93 risk signals were related to Gd-BOPTA, 79 risk signals were relevant 
      to Gd-HP-DO3A, and 101 risk signals were associated with Gd-BT-DO3A. The AE 
      signals involved 20 system organ classes (SOCs). Two of the top four SOCs were 
      identical, namely 'skin and subcutaneous tissue disorders' and 'general disorders 
      and administration site conditions.' CONCLUSIONS: The safety signals of 4 GBCAs 
      were detected, and the SOCs associated with the AEs of the 4 GBCAs were 
      different. Besides, some AEs obtained in this study were not mentioned in the 
      package inserts, which need more attention and research to ensure the clinical 
      safety.
FAU - Wang, Lu
AU  - Wang L
AUID- ORCID: 0000-0002-2752-2234
AD  - Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai, Shandong, P. R. 
      China.
FAU - Wang, Yinglin
AU  - Wang Y
AUID- ORCID: 0000-0001-5013-9834
AD  - Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai, Shandong, P. R. 
      China.
FAU - Zhao, Quan
AU  - Zhao Q
AUID- ORCID: 0000-0001-8861-9868
AD  - Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai, Shandong, P. R. 
      China.
LA  - eng
PT  - Journal Article
DEP - 20231024
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0199MV609F (gadoteridol)
RN  - 0 (Contrast Media)
RN  - 15G12L5X8K (gadobenic acid)
RN  - K2I13DR72L (Gadolinium DTPA)
RN  - AU0V1LM3JT (Gadolinium)
RN  - 0 (Heterocyclic Compounds)
RN  - 6HG8UB2MUY (Meglumine)
RN  - 0 (Organometallic Compounds)
SB  - IM
MH  - United States
MH  - Humans
MH  - *Contrast Media/adverse effects
MH  - *Gadolinium DTPA/adverse effects
MH  - Gadolinium/adverse effects
MH  - United States Food and Drug Administration
MH  - Data Mining
MH  - *Heterocyclic Compounds
MH  - Meglumine/*analogs & derivatives
MH  - *Organometallic Compounds
OTO - NOTNLM
OT  - FAERS
OT  - Gadolinium-based contrast agent
OT  - drug-related adverse events
OT  - potential risk signal
OT  - system organ class
EDAT- 2023/10/15 05:43
MHDA- 2024/03/08 06:43
CRDT- 2023/10/14 07:12
PHST- 2024/03/08 06:43 [medline]
PHST- 2023/10/15 05:43 [pubmed]
PHST- 2023/10/14 07:12 [entrez]
AID - 10.1080/14740338.2023.2271834 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Mar;23(3):339-352. doi: 10.1080/14740338.2023.2271834. 
      Epub 2023 Oct 24.