Prevalence of adverse reactions in nuclear medicine. Pharmacopeia Committee of the Society of Nuclear Medicine.

Abstract

This investigation sought to determine the prevalence of adverse reactions to radiopharmaceuticals and to nonradioactive drugs used in interventional nuclear medicine. We also tabulated all adverse reactions reported to manufacturers of radiopharmaceuticals commercially available in the United States. A prospective 5-yr study was performed of 18 collaborating institutions using a questionnaire which enumerated monthly the number of procedures used and adverse reactions noted. An algorithm to determine the level of etiologic probability of an adverse reaction from an administered radiopharmaceutical was developed. We reviewed all available literature on adverse reactions in nuclear medicine. During this period, 783,525 radiopharmaceutical and 67,835 nonradioactive drug administrations were analyzed. Ten of the 18 adverse reactions to radiopharmaceuticals were rashes. No patient experiencing an adverse reaction to a radiopharmaceutical required hospitalization or had significant sequelae. Reproducibility of the adverse reactions algorithm was validated by independent evaluation of 30 adverse reaction reports from the U.S. Pharmacopeia-Society of Nuclear Medicine adverse reaction reporting system. All adverse reactions to 49 commercially available radiopharmaceuticals were tabulated and referenced. Radiopharmaceuticals have an excellent safety record. An algorithm to evaluate putative radiopharmaceutical reactions is highly reproducible.