Abstract

¬INSIGHTS INTO APPROVED RADIOPHARMACEUTICALS IN USA AND THEIR POTENTIAL SIDE EFFECTS

P. Naga Lakshmi* and G. Kavya Latha

ABSTRACT

Aim: To provide a comprehensive overview of approved radiopharmaceuticals in the United States, focusing on their regulatory pathways, post-marketing surveillance, and safety monitoring practices.Objectives• To identify the key regulatory agencies involved in the approval and oversight of radiopharmaceuticals in the USA.• To describe the stringent approval process employed by the FDA for radiopharmaceutical agents.• To highlight the importance of post-marketing surveillance in monitoring the safety and efficacy of radiopharmaceuticals. Methodology: The study aimed to identify adverse effects associated with approved radiopharmaceuticals in the USA, utilizing the FDA Drug Information Database as the primary data source. This database provides comprehensive information on approved drugs, including. Their indications, dosages, and reported adverse effects. Supplementary data were gathered from peer-reviewed articles, clinical trial reports, and guidelines from the NRC and SNMMI. The collected adverse effects were analyzed to assess the safe use of these radiopharmaceuticals in clinical practice. Results: The analysis of FDA-approved radiopharmaceuticals from 1971 to 2023 reveals a diverse range of agents used for diagnostic and therapeutic purposes, each with distinct safety profiles. While some agents, such as Carbon 14 urea and Fluorine 18 sodium fluoride, report no side effects, others exhibit common adverse reactions including injection site reactions (75%) and nausea (45%). Notably, therapeutic agents like Iodine 131 sodium iodide may cause low-frequency side effects such as bone marrow suppression and organ- specific toxicities, indicating the necessity for careful evaluation of risk-benefit profiles in clinical applications. Conclusion: The analysis of FDA-approved radiopharmaceuticals from 1971 to 2023 highlights diverse safety profiles, with some agents reporting no adverse effects while others exhibit common and serious reactions. Ongoing monitoring of these risk-benefit profiles is essential to ensure patient safety and optimize therapeutic outcomes in clinical practice.

Keywords: Radiopharmaceuticals, Regulations, Nuclear medicine, FDA Approval, Radiation safety, Therapeutic Agents, Diagnostic Imaging, post-marketing surveillance.¬