Ultrasound contrast media in paediatric patients: is it an off-label use? Regulatory requirements and radiologist’s liability

Abstract

The use of ultrasound contrast media is yet to be validated in children. The rare reports in the scientific literature denote their "sporadic" and "experimental" use. Their most likely use is in the setting of off-label prescription of medications. As there are still no guidelines available in Italy for the off-label use of medications, we aim to define the duties, obligations and liability of ultrasound radiologists according to the laws in force.

Transfontanellar contrast enhanced ultrasound in infants: Initial experience

“…This is mainly due to fact that US contrast media in children are currently used off label only [27] as effectiveness and safety of contrast media in patients < 18 years of age have not yet been evaluated [27].…”

US detection of renal and ureteral calculi in patients with suspected renal colic

“…It is possible to differentiate between these entities: when the twinkling sign is produced by vascular calcifications, it appears near a structure that at the same time produces a pulsing color signal due to the blood flow [19-22]. When the twinkling sign is produced by intraparenchymal calcifications, it differs from lithiasis due to its parenchymal location [23-25]. …”

Untitled

“…In Europe, CEUS in children is mostly "off-label" use, except for a few indications including vesico-ureteral reflux [64]. The same is true for many drugs, which are used off-label in paediatric practice and the question of "off label use" has been widely discussed [65,66]. The recent approval of SonoVue™/Lumason™ for use in paediatrics in the United States is a welcome first step towards the acceptance of this technique in the non-ionising imaging of children [67].…”