[Administration of MR contrast agents outside of approved indications (off-label use]

Abstract

Purpose: The use of MRI contrast agents outside their labeled indications is routine in radiology. However, physicians feel frequently at unease. It is the aim of this paper to introduce the medical, juridicial and billing relevant issues in order to improve the knowledge on this topic.

Methods: The basis for off-label use is the physician's prerogative, which finds its basis in the "declaration of Helsinki".

Results: Off-label use is allowed under special conditions and might be even the medical state of the art.

Conclusion: The necessity for off-label use will continue to increase for MR-contrast agents, as clinical trials for registration purpose are quite costly and manufactures continuously will concentrate on the essential indications.