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Thyroid dysfunction associated with iodine-contrast media: A real-world pharmacovigilance study based on the FDA
Lu Huang1,2,3, Yan Luo1,2,4, Zhen-Lin Chen3
1Department of Pharmacy, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Insights
Iodine contrast media (ICM) can cause thyroid dysfunction, including hypothyroidism and hyperthyroidism, often within 30 days of administration. Iodixanol showed the highest risk, necessitating thyroid function monitoring for high-risk agents.
Area of Science:
- Endocrinology
- Radiology
- Pharmacovigilance
Background:
- Iodine contrast media (ICM) are widely used in medical imaging.
- ICM administration can potentially affect thyroid function.
- Understanding the specific risks of ICM-induced thyroid dysfunction is crucial for patient safety.
Purpose of the Study:
- To analyze the characteristics of thyroid dysfunction associated with ICM.
- To identify specific ICM agents posing a higher risk for thyroid dysfunction.
- To evaluate the temporal relationship and severity of ICM-related thyroid events.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database.
- Employed disproportionate analysis to detect safety signals for thyroid dysfunction.
- Conducted descriptive analysis of clinical characteristics of reported cases.
Main Results:
- 83 reports of thyroid dysfunction linked to ICM were identified.
- ICM significantly increased reporting of hypothyroidism (ROR=2.21) and hyperthyroidism (ROR=3.49).
- Iodixanol showed the highest signal for both hypothyroidism (ROR=9.47) and hyperthyroidism (ROR=5.44).
- Most cases occurred within 30 days of ICM administration.
- Severe outcomes were more frequent in hyperthyroidism (12/26) than hypothyroidism (2/35).
Conclusions:
- Different ICM agents carry varying risks of thyroid dysfunction, with iodixanol being a notable concern.
- Thyroid dysfunction following ICM typically manifests within the first month.
- Monitoring thyroid function post-administration is recommended, especially for higher-risk ICM agents.
Objective:
To comprehensively analyze characteristics of thyroid dysfunction associated with iodine contrast media (ICM) based on data from the FDA adverse event reporting system (FAERS).
Methods:
Disproportionate analysis was employed to identify signals of thyroid dysfunction caused by ICM, and descriptive analysis was performed to examine the clinical characteristics of reported cases involving ICM-related thyroid dysfunctions.
Results:
A total of 83 adverse event reports were identified, documenting thyroid dysfunctions associated with ICM agents. Treatment with ICM was significantly associated with higher reporting of hypothyroidism ([ROR] = 2.21, 95 % CI: 1.59-3.08; IC025 = 0.58) and hyperthyroidism (ROR = 3.49, 95 % CI: 2.37-5.13; IC025 = 1.14). Among the six ICM agents investigated, iodixanol demonstrated the highest signal strength in both hypothyroidism (ROR = 9.47) and hyperthyroidism (ROR = 5.44). Hypothyroidism and hyperthyroidism almost occurred in the first 30 days after ICM administration (76.9 % and 70 % of patients, respectively). Furthermore, the proportion of severe outcomes in hyperthyroidism was significantly higher than that in hypothyroidism (12/26 vs. 2/35, P = 0.009).
Conclusion:
The present study highlights the varying risks of thyroid dysfunction associated with different ICM agents, with iodixanol exhibiting the highest signal intensity. Hypothyroidism and hyperthyroidism associated with ICM generally manifest within the first month following administration. Consequently, monitoring of thyroid function during this period is strongly recommended for ICM agents presenting higher risk profiles.
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