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Off-label use of contrast agents

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Abstract

When contrast agents are approved, the label describes the approved indications and particular circumstances of use such as age, organ function or pregnancy. The use of contrast agents outside their labelled indications is increasing, namely with contrast agents used for MRI. The aim of this paper is to improve the knowledge about this topic. The basis for off-label use is the physician’s prerogative, which finds its basis in the “Declaration of Helsinki”. Off-label use is allowed under special conditions and might be even the medical state of the art. The necessity for off-label use will continue to increase for MR-contrast agents, as the regulatory requirements for approval of new indications continuously increase, and clinical trials for registration purposes are quite costly and time consuming. As a consequence, manufacturers will concentrate on clinical studies for the essential indications.

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Acknowledgements

We thank Henrik Thomsen from Copenhagen University Hospital, Martin Schmidt from the Department of Pharmacology at Klinikum Karlsruhe, Christiane Pering from Bayer Health/Schering, Michel Schafer from Guerbet and Klaus-Peter Lodemann from Altana/Byk-Gulden for helpful comments.

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Authors and Affiliations

  1. Radiology, Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Moltkestraße 90, 76133, Karlsruhe, Germany

    P. Reimer

  2. Radiology Group, MRI at Friederikenstift, Humboldtstr. 5, 30169, Hannover, Germany

    R. Vosshenrich

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  1. P. Reimer
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  2. R. Vosshenrich
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Correspondence to P. Reimer.

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Reimer, P., Vosshenrich, R. Off-label use of contrast agents. Eur Radiol 18, 1096–1101 (2008). https://doi.org/10.1007/s00330-008-0886-0

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  • DOI: https://doi.org/10.1007/s00330-008-0886-0

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