False-Positive Results of Radionuclide Imaging in Lactating Breasts: a pharmacovigilance perspective
Open Access
- 8 April 2020
- journal article
- Published by Global Clinical and Translational Research Institute in Global Clinical and Translational Research
Abstract
Background: Misleading diagnostic results, including false-positives, potentially impact both the safety and efficacy profiles of radiopharmaceuticals used for diagnostic purposes. It is unclear, however, if false-positives occurring with radio-pharmaceuticals in lactating breasts are regularly reported as adverse events. Methods: Scientific medical literature (PubMed and Google Scholar) and the EudraVigilance database of suspected adverse drug reaction reports were searched for case reports of false-positives with radiopharmaceuticals appearing in lactating breasts. Medical Dictionary for Regulatory Activities (MedDRA) was reviewed for terms that could be used to capture reports of false-positives occurring in breast nuclear imaging accurately. Results: Literature searches showed that 40 case reports of false-positives have been observed with radiopharmaceuticals in lactating breasts but that these do not appear to be consistently reported to EudraVigilance as adverse events. MedDRA did not contain terms suitable for capturing false-positives in breasts with radiopharmaceuticals, but newly proposed terms were all approved. Conclusion: Increased reporting of false-positives as adverse events could help further clarify the safety specification of radiopharmaceuticals.Keywords
This publication has 23 references indexed in Scilit:
- Ethical GuidelineChinese Herbal Medicines, 2018
- Lactation has persistent effects on a mother’s metabolism and mitochondrial functionScientific Reports, 2017
- Spectrum of the Breast Lesions With Increased 18F-FDG Uptake on PET/CTClinical Nuclear Medicine, 2016
- Directive 2008/104/EC of the European Parliament and of the Council of 19 November 2008Published by Springer Science and Business Media LLC ,2015
- Incidental Breast Lesions Identified by18F-FDG PET/CT: Which Clinical Variables Differentiate between Benign and Malignant Breast Lesions?Journal of Breast Cancer, 2015
- Pharmacovigilance in pharmaceutical companies: An overviewJournal of Pharmacology and Pharmacotherapeutics, 2013
- Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: ICH M3 and M3(R2)Published by Springer Science and Business Media LLC ,2013
- Unilateral breast uptake of Tc-99m pertechnetate in a patient with cold nodule of the thyroidWorld Journal of Nuclear Medicine, 2012
- individual case safety report (ICSR)Published by Springer Science and Business Media LLC ,2009
- Reviewer Guidance: Review of Human Pregnancy Outcome DataPublished by Test accounts ,1999