False-Positive Results of Radionuclide Imaging in Lactating Breasts: a pharmacovigilance perspective

Vojislav Kišić1 and Jennifer Parish2

1University of Belgrade School of Medicine, Dr. Subotića 8, 11000 Belgrade, Serbia.

2IQVIA, Leskoškova cesta 2, 1000 Ljubljana, Slovenia.

Received March 2, 2020; Revised March 20, 2020; Accepted April, 2020


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.


Radiotracers; lactation; pharmacovigilance; adverse events; false-positives.

Copyright © 2020 by the author(s). Licensee Global Clinical and Translational Research. This is an open-access article distributed under the terms and conditions of the Creative Commons Attribution License (CCBY4.0, https:// /licenses /by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium provided the original work is properly cited.

How to cite this article:

Kisic V, Parish J. False-positive results of radionuclide imaging in lactating breasts: a pharmacovigilance perspective. Glob Clin Transl Res. 2020; 2 (2): 38-45. DOI:10.36316/gcatr.01.0029.


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