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Adverse reactions by radiopharmaceuticals: Retrospective analysis of the Portuguese National Pharmacovigilance System

2025Artigo de investigação Acesso aberto
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dc.contributor.authorMartins, Sara
dc.contributor.authorJesus, Ângelo
dc.contributor.authorAndrade, Ricardo
dc.contributor.authorRocha, Mariana
dc.contributor.authorMartín-Suarez, Ana
dc.contributor.authorJesus, Ângelo
dc.date.accessioned2026-04-13T09:27:38Z
dc.date.available2026-04-13T09:27:38Z
dc.date.issued2025
dc.description.abstractRadiopharmaceuticals are essential in the field of nuclear medicine, but like any other medicinal product, radiopharmaceuticals can potentially cause adverse reactions in patients. To describe the adverse reactions to radiopharmaceuticals reported to the Portuguese National Pharmacovigilance System (SNF). Methods: We performed a retrospective, observational study by examining individual case safety reports (ICSRs) provided by the SNF related to all radiopharmaceuticals commercially available in Portugal from 2010 to 2023. The SNF received a total of 84 ICSRs. These reports resulted in a total of 224 adverse drug reactions (ADR), which involved a total of 15 different radiopharmaceuticals. The mean age of patients was 61.9 years old. Twenty-one different system organ classes (SOCs) were identified, with the most prevalent situations being “Gastrointestinal Disorders” (18.3%; n = 41) followed by “General disorders and administration site conditions” (16.5%; n = 37), “Skin and subcutaneous tissue disorders” (11.2%; n = 25) and “Blood and lymphatic system disorders” (10.3%; n = 23). Fifty-seven reports (67.85%) showed at least 1 serious ADR. Most notified radiopharmaceuticals were, respectively, radium—223 (n = 36, 41.4%), lutetium-177 oxotreotide (n = 12, 13.8%) and iodide—131 (n = 9, 10.3%). Although the number of notifications is limited, these findings provide valuable insights into the types and frequencies of adverse reactions associated with radiopharmaceuticals used in Portugal between 2010 and 2023. The data highlight the importance of continued pharmacovigilance efforts to monitor the safety of these specialized medical products and inform clinical decision-making.eng
dc.identifier.citationMartins, S., Jesus, Â., Andrade, R., Rocha, M., & Martín-Suarez, A. (2025). Adverse reactions by radiopharmaceuticals: Retrospective analysis of the Portuguese National Pharmacovigilance System. Annals of Pharmacotherapy, 59(10), 919–927. https://doi.org/10.1177/10600280251316542
dc.identifier.doi10.1177/10600280251316542
dc.identifier.eissn1542-6270
dc.identifier.issn1060-0280
dc.identifier.urihttp://hdl.handle.net/10400.22/32219
dc.language.isoeng
dc.peerreviewedyes
dc.publisherSage
dc.relationLA/P/0008/2020; UIDP/50006/2020; UIDB/50006/2020
dc.relation.hasversionhttps://journals.sagepub.com/doi/10.1177/10600280251316542
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectRadioisotopes
dc.subjectDrug safety
dc.subjectAdverse drug reactions
dc.subjectNuclear medicine
dc.subjectHospital pharmacy
dc.titleAdverse reactions by radiopharmaceuticals: Retrospective analysis of the Portuguese National Pharmacovigilance Systemeng
dc.typeresearch article
dspace.entity.typePublication
oaire.citation.endPage927
oaire.citation.issue10
oaire.citation.startPage919
oaire.citation.titleAnnals of Pharmacotherapy
oaire.citation.volume59
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameJesus
person.givenNameÂngelo
person.identifier.ciencia-idA91F-3585-4F42
person.identifier.orcid0000-0003-3972-8253
person.identifier.ridA-4404-2012
person.identifier.scopus-author-id56153841300
relation.isAuthorOfPublication1cbff3da-9800-4bd7-8d84-fd8d9ca819b2
relation.isAuthorOfPublication.latestForDiscovery1cbff3da-9800-4bd7-8d84-fd8d9ca819b2

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