Off-label use of contrast agents

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.

Off-label use of intravascular iodinated organic and MR contrast media

“…Recent data published in the literature suggest that, in general, the off-label use of drugs is a routine practice in 23% of prescriptions [12] and that off-label use is widely practised in various specialities to the point of being standard practice in paediatrics and intensive care. It is worth noting that there is currently a lack of sufficient and accurate data to define the extent of this phenomenon in diagnostic imaging.…”

“…In diagnostic imaging, the off-label use of contrast media [12] mostly involves gadolinium-based contrast media, especially in MR angiography, cardiac and paediatric applications [13,14] and patients younger than 2 years [15]. The off-label use must be based on scientific evidence, serve the patient's best interest, and requires greater care than would generally be the case in medical-radiological practice [16].…”

“…In diagnostica per immagini l'utilizzo off-label dei mezzi di contrasto [12] trova applicazione con maggiore frequenza per quanto riguarda gli agenti di contrasto a base di gadolinio (Gd), e segnatamente in angiografia mediante RM, in applicazioni cardiache e pediatriche [13,14], ed in pazienti di età inferiore ai due anni [15]. L'uso off-label si deve basare sulle evidenze scientifiche, utilizzate nel miglior interesse del paziente, e richiede prudenza maggiore di quella che deve essere comunque esercitata nella pratica medico-radiologica in generale [16].…”

“…Dai dati più recenti della letteratura emerge che in generale l'uso di farmaci off-label è una pratica routinaria in circa il 23% delle prescrizioni [12] e che comunque l'off-label è ampiamente diffuso in varie specialità rappresentando finanche una pratica standard in età pediatrica ed in terapia intensiva. Ed a tale proposito si precisa che mancano allo stato dati precisi e sufficienti per definire l'entità di questo fenomeno in diagnostica per immagini.…”

Recent hot topics in contrast media

“…When contrast agents are approved, the label describes the approved indications and particular circumstances of use, such as age, organ function or pregnancy [15]. The use of contrast agents outside the indications on the label is increasing rapidly.…”