Evaluation of Radiopharmaceutical Adverse Reaction Reports to the British Nuclear Medicine Society from 2007 to 2016.

Abstract

This study sought to answer the calls that have been made for the European Association of Nuclear Medicine to restore its surveys of reported adverse reactions. We assessed all reports of adverse reactions to radiopharmaceuticals that were submitted to the British Nuclear Medicine Society (BNMS) online database (Radiopharmaceutical Adverse Events and Product Defects) from January 2007 to December 2016. <b>Methods:</b> This investigation was a pharmacovigilance-based, nonexperimental, cross-sectional study aimed at finding the prevalence of, and association between, radiopharmaceuticals and adverse reactions. <b>Results:</b> During the study period, there were 204 reports of radiopharmaceutical adverse reactions, of which 13 were considered invalid, primarily because of incomplete entries or because a causal relationship between the radiopharmaceutical and the adverse reaction could not be determined. Tetrofosmin (34 reports) and oxidronate (32 reports) had the highest prevalence, followed by medronate (21 reports) and then sestamibi and nanocolloid (14 reports each). Rash (84 reports), itching (46 reports), and vomiting (30 reports) were the 3 most frequently occurring adverse reactions. Most reports (96.8%) were for diagnostic radiopharmaceuticals. <b>Conclusion:</b> The prevalence of adverse reactions to radiopharmaceuticals reported in the BNMS database remains low, with a frequency of 3.1 reports per 100,000 administrations in 2013 and 2.5 per 100,000 administrations in 2015. In our review spanning 10 years, we did not find any particular concern about the use of radiopharmaceuticals.