Adverse Reactions to Radiopharmaceuticals: Retrospective analysis of the Spanish Pharmacovigilance System
DOI:
https://doi.org/10.60103/phc.v27.e900Keywords:
Pharmacovigilance, Adverse reactions, RadiopharmaceuticalsAbstract
Introduction: Radiopharmaceuticals have become indispensable tools in modern medicine, but like any other medication, they can cause adverse reactions in patients. The objective of this study was to analyze reports of suspected adverse reactions (ADR) related to radiopharmaceuticals in the Spanish healthcare context.
Method: An observational, cross-sectional, retrospective and descriptive study was carried out, focusing on the analysis of spontaneous notifications of adverse reactions associated with the use of radiopharmaceuticals (ADRr), submitted to the Spanish Pharmacovigilance System for Medicinal Products for Human Use, during the period from 2010 to 2023.
Results: A total of 518 spontaneous reports were received, resulting in 1717 ADRs. 53.1% of the reactions were considered serious. Radium (223Ra) dichloride was the most frequently identified radiopharmaceutical in the reports (29.4%), and of the 37 deaths reported in reports associated with the administration of radiopharmaceuticals, 22 occurred with this radiopharmaceutical.
Conclusions: Radiopharmaceuticals have a lower incidence of reported ADRs compared to conventional medicines, but the possibility of their occurrence cannot be completely ruled out, with serious consequences in some cases. The fact that only 518 reports have been submitted in 14 years confirms suspicions of underreporting by professionals, patients, and others. Further awareness-raising and training measures are needed to increase the reporting of potential ADRr.
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