False-Positive Results of Radionuclide Imaging in Lactating Breasts: A Pharmacovigilance Perspective
V Kišić, J Parish
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.