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- Contributions to the study of adverse reactions mediated by radiopharmaceuticalsPublication . Oliveira, Diana Lopes de; Jesus, Ângelo Miguel CardosoIn contemporary Nuclear Medicine, radiopharmaceuticals are essential since they enable physicians to cure severe illnesses like cancer in addition to seeing what's going on inside the body. However, monitoring these compounds' possible hazards and side effects is still a challenging and undeveloped area of pharmacovigilance since they include radioactivity, behave in complex ways within the body, and frequently lack long-term safety data. This dissertation aims to contribute to the study of adverse reactions associated to the radiopharmaceuticals through a two-part approach. The first section critically evaluates the methodological quality of scientific publications involving Strontium-89, Samarium-153-EDTMP, Rhenium-186-HEDP, Rhenium-188-HEDP, and Lutetium-177 compounds, using a structured assessment tool to determine their evidentiary strength in relation to safety outcomes. The second section presents a retrospective and descriptive analysis of adverse reaction reports related to Radium-223, as submitted to the EudraVigilance European database. The results highlight that although therapeutic radiopharmaceuticals generally demonstrate a favourable safety profile, haematological toxicity—particularly leukopenia and thrombocytopenia—is the most frequently reported adverse event. The spontaneous reporting system continues to encounter numerous obstacles, including data restrictions in vulnerable populations, conflicting causality assessments, and underreporting. To guarantee patient safety, this work emphasizes the significance of incorporating pharmacovigilance techniques specific to radiopharmaceuticals, encouraging structured reporting, and raising clinical awareness.
