PMID- 35471204
OWN - NLM
STAT- MEDLINE
DCOM- 20220908
LR  - 20230926
IS  - 1536-0210 (Electronic)
IS  - 0020-9996 (Print)
IS  - 0020-9996 (Linking)
VI  - 57
IP  - 10
DP  - 2022 Oct 1
TI  - Use of Real-Life Safety Data From International Pharmacovigilance Databases to 
      Assess the Importance of Symptoms Associated With Gadolinium Exposure.
PG  - 664-673
LID - 10.1097/RLI.0000000000000880 [doi]
AB  - OBJECTIVE: Recent scientific publications have reported cases of patients who 
      complained from a variety of symptoms after they received a gadolinium-based 
      contrast agent (GBCA). The aim of this study was to appreciate the importance of 
      these clinical manifestations in the overall population by assessing the weight 
      of "symptoms associated with gadolinium exposure" (SAGE) among the bulk of safety 
      experiences reported to major health authorities. MATERIALS AND METHODS: Symptoms 
      associated with gadolinium exposure were identified from a review of the 
      scientific literature, and the corresponding preferred terms were searched in 
      each system organ class (SOC) category recorded in the European and North 
      American pharmacovigilance databases EudraVigilance (EV) and FDA Adverse Event 
      Reporting System (FAERS), respectively. The numbers of SAGE per preferred term, 
      and cumulatively per SOC, were recorded and their weights in the overall spectrum 
      of adverse events (AEs) were determined for each GBCA. RESULTS: The analysis of 
      the selected AEs revealed a significantly higher SAGE weight for gadobenate 
      dimeglumine (EV: 25.83%, FAERS: 32.24%) than for gadoteridol (EV: 15.51%; FAERS: 
      21.13%) and significantly lower SAGE weights for gadobutrol (EV: 7.75%; FAERS: 
      13.31%) and gadoterate meglumine (EV: 8.66%; FAERS: 12.99%). A similar ranking 
      was found for most of the SOCs except for "nervous system disorders," probably 
      owing to a limitation in the methods of data selection. Furthermore, this 
      analysis showed a greater percentage of reports mentioning a decrease in the 
      quality of life of the patients when they were exposed to gadobenate dimeglumine 
      or gadoteridol than to gadobutrol or gadoterate meglumine. CONCLUSION: This study 
      showed that SAGE represent a significant percentage of the bulk of AEs reported 
      to the health authorities for each GBCA. It provided real-life arguments 
      suggesting that SAGE may be more prevalent with linear than macrocyclic GBCAs and 
      that gadoteridol may present a higher SAGE risk than the other macrocyclic 
      contrast agents.
CI  - Copyright (c) 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Shahid, Imran
AU  - Shahid I
AD  - From the Vigilance and Medical Information Department, Guerbet, Roissy CDG Cedex, 
      France.
FAU - Joseph, Alvin
AU  - Joseph A
FAU - Lancelot, Eric
AU  - Lancelot E
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20220426
PL  - United States
TA  - Invest Radiol
JT  - Investigative radiology
JID - 0045377
RN  - 0 (Contrast Media)
RN  - 0 (Organometallic Compounds)
RN  - 6HG8UB2MUY (Meglumine)
RN  - AU0V1LM3JT (Gadolinium)
RN  - K2I13DR72L (Gadolinium DTPA)
SB  - IM
CIN - Invest Radiol. 2022 Oct 1;57(10):674-676. PMID: 35703449
MH  - Contrast Media/adverse effects
MH  - *Gadolinium/adverse effects
MH  - Gadolinium DTPA/adverse effects
MH  - Humans
MH  - Meglumine/adverse effects
MH  - *Organometallic Compounds/adverse effects
MH  - Pharmacovigilance
MH  - Quality of Life
PMC - PMC9444285
COIS- Conflicts of interest and sources of funding: I. Shahid, A. Joseph, and E. 
      Lancelot are employees of Guerbet.
EDAT- 2022/04/27 06:00
MHDA- 2022/09/09 06:00
PMCR- 2022/09/05
CRDT- 2022/04/26 12:35
PHST- 2022/04/27 06:00 [pubmed]
PHST- 2022/09/09 06:00 [medline]
PHST- 2022/04/26 12:35 [entrez]
PHST- 2022/09/05 00:00 [pmc-release]
AID - 00004424-202210000-00004 [pii]
AID - IR_220127 [pii]
AID - 10.1097/RLI.0000000000000880 [doi]
PST - ppublish
SO  - Invest Radiol. 2022 Oct 1;57(10):664-673. doi: 10.1097/RLI.0000000000000880. Epub 
      2022 Apr 26.