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

ABSTRACTBackground 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.KEYWORDS: Gadolinium-based contrast agentdrug-related adverse eventspotential risk signalsystem organ classFAERS Declaration of interestsThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.Reviewer disclosuresPeer reviewers on this manuscript have no relevant financial or other relationships to disclose.Data availability statementThe AE data used to support the findings of this study are openly available in OpenVigil 2.1 website platform at http://h2876314.stratoserver.net:8080/OV2/search/.Authors' contributionsThe contributions of the respective authors are as follows: Q Zhao and Y Wang carried out the design of this study and contributed to the critical revision of the manuscript. L Wang and Y Wang performed the collect of the data. L Wang performed the analysis of the data, and statistical analysis, and drafted the manuscript. All authors approved the final version.Ethics statementAnonymized data were collected from a publicly available database and did not require ethics committee approval.Supplementary materialSupplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2271834Additional informationFundingThis work was funded by the Shandong Drug Adverse Reaction Monitoring Center under Grant 2022SDADRKY24.