Expert opinion on drug safety · 2024
Anaphylactic risk associated with iodinated and gadolinium-based contrast media.
СтатьяНазвание и аннотация: Перевод в очереди
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Bian Sainan, Wang Zixi, Li Lisha, Cui Le, Xu Yingyang, Guan Kai, Zhao Bin, Xue Huadan
Аннотация
BACKGROUND: This study aimed to analyze the risk signals of iodinated and gadolinium-based contrast media associated with anaphylaxis.
RESEARCH DESIGN AND METHODS: Data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) were retrospectively reviewed from January 2004 to September 2022. Disproportionality and Bayesian analyses were used in data mining to screen for suspected anaphylaxis using contrast media.
RESULTS: A total of 1240 reports of anaphylaxis associated with contrast media were identified (464 men, 37.4%). The average age of anaphylaxis associated with iodinated contrast media (ICM) and gadolinium-based contrast media (GBCM) was 56.8 ± 17.2 and 50.9 ± 18.0 years old, respectively (p < .001). Among ICM, iopamidol showed the highest reporting odds ratio (ROR) (29.0), and amidotrizoate showed the lowest ROR (7.4). Among low-osmolality ICM, iopamidol had the highest ROR (29.0), and iopromide had the lowest ROR (8.8). Among the macrocyclic agents, gadoteridol had the highest ROR (37.3), while gadoterate meglumine had the lowest (10.4). Among the linear agents, gadobenate dimeglumine had the highest ROR (28.8), and gadodiamide had the lowest (1.4). The mortality rate in ICM was significantly higher than that in GBCM (p < 0.001).
CONCLUSIONS: This study provides clinicians and pharmacists evidence for risk signals of anaphylactic reactions among contrast agents.
RESEARCH DESIGN AND METHODS: Data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) were retrospectively reviewed from January 2004 to September 2022. Disproportionality and Bayesian analyses were used in data mining to screen for suspected anaphylaxis using contrast media.
RESULTS: A total of 1240 reports of anaphylaxis associated with contrast media were identified (464 men, 37.4%). The average age of anaphylaxis associated with iodinated contrast media (ICM) and gadolinium-based contrast media (GBCM) was 56.8 ± 17.2 and 50.9 ± 18.0 years old, respectively (p < .001). Among ICM, iopamidol showed the highest reporting odds ratio (ROR) (29.0), and amidotrizoate showed the lowest ROR (7.4). Among low-osmolality ICM, iopamidol had the highest ROR (29.0), and iopromide had the lowest ROR (8.8). Among the macrocyclic agents, gadoteridol had the highest ROR (37.3), while gadoterate meglumine had the lowest (10.4). Among the linear agents, gadobenate dimeglumine had the highest ROR (28.8), and gadodiamide had the lowest (1.4). The mortality rate in ICM was significantly higher than that in GBCM (p < 0.001).
CONCLUSIONS: This study provides clinicians and pharmacists evidence for risk signals of anaphylactic reactions among contrast agents.