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.
Highlights
Additional copies of this Guidance are available from: Division of Drug Information HFD-240 Center for Drug Evaluation and Research
The three guidances are: Part 1: Conducting Safety Assessments; Part 2: Clinical Indications; and Part 3: Design, Analysis, and Interpretation of Clinical Studies. 29 Medical imaging agents generally are governed by the same regulations as other drug and 30 biological products
This guidance has been prepared by the Division of Medical Imaging and Radiopharmaceutical Drug Products and the Office of Therapeutics Research and Review in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration
Summary
Additional copies of this Guidance are available from: Division of Drug Information HFD-240 Center for Drug Evaluation and Research. Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research. 29 Medical imaging agents generally are governed by the same regulations as other drug and biological products. This guidance discusses our recommendations on conducting safety assessments of medical imaging agents. This guidance has been prepared by the Division of Medical Imaging and Radiopharmaceutical Drug Products and the Office of Therapeutics Research and Review in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.
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