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

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.