PREVALENCE OF ADVERSE REACTIONS IN NUCLEAR-MEDICINE

This investigation sought to determine the prevalence of adverse react ions to radiopharmaceuticals and to nonradioactive drugs used in inter ventional nuclear medicine. We also tabulated all adverse reactions re ported to manufacturers of radiopharmaceuticals commercially available in the United States. Methods: A prospective 5-yr study was performed of 18 collaborating institutions using a questionnaire which enumerat ed monthly the number of procedures used and adverse reactions noted. An algorithm to determine the level of etiologic probability of an adv erse reaction from an administered radiopharmaceutical was developed. We reviewed all available literature on adverse reactions in nuclear m edicine. Results: During this period, 783,525 radiopharmaceutical and 67,835 nonradioactive drug administrations were analyzed. Ten of the 1 8 adverse reactions to radiopharmaceuticals were rashes. No patient ex periencing an adverse reaction to a radiopharmaceutical required hospi talization or had significant sequelae. Reproducibility of the adverse reactions algorithm was validated by independent evaluation of 30 adv erse reaction reports from the U.S. Pharmacopeia-Society of Nuclear Me dicine adverse reaction reporting system. All adverse reactions to 49 commercially available radiopharmaceuticals were tabulated and referen ced. Conclusion: Radiopharmaceuticals have an excellent safety record. An algorithm to evaluate putative radiopharmaceutical reactions is hi ghly reproducible.