A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) for therapeutic radiopharmaceuticals

Abstract

Purpose: The present study investigates the adverse events (AEs) associated with therapeutic radiopharmaceuticals, as reported to the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) from 1969 to 2024.

Methods: An extensive data set on cases of AEs was retrieved from the FAERS and subsequently analyzed regarding total case numbers, age distribution, and sex differences. Descriptive statistics were used to identify frequently reported AEs, and a Chi-square test was employed to assess the statistical significance of sex differences. The reporting odds ratio (ROR) and the 95 % confidence intervals were determined.

Results: Over the 56 years, there has been a marked increase in the number of reported AEs associated with therapeutic radiopharmaceuticals. Despite their relative novelty, the highest number of cases were reported in association with ¹⁷⁷Lu (n = 12,706) and ²²³Ra (n = 4875). Conversely, ¹³¹I has a longstanding history of use, but it ranks third in terms of AE (n = 2600). The number of these AE cases is higher in males, except for iodine radiopharmaceuticals. As a result of ROR analysis, various signals were detected, including endocrine ophthalmopathy, respiratory disorders, and jaw osteonecrosis AE, which are not included in the prescribing information of the drugs.

Conclusions: The increase in the number of AEs reported with therapeutic radiopharmaceuticals may be due to both the increased use of these medications and improved pharmacovigilance systems. The development of strategies to enhance the efficacy and safety of therapeutic radiopharmaceuticals may be facilitated through studies that establish a causal relationship between these signals and medications.

Keywords: Adverse events; Drug safety; Odds ratio; Pharmacovigilance; Therapeutic radiopharmaceuticals.