FDA perspective on ultrasound contrast agents safety and development

Abstract

Regulatory actions through 2007-2008 demonstrate FDA's response to multiple reports of sudden death and severe cardiopulmonary reactions temporally related to the administration of Ultrasound Contrast Agents (UCA). Certain animal data showed similar adverse effects at a clinically relevant dose. The products labels were changed to include the boxed warning encouraging healthcare providers to assess patients for contraindications and to monitor patients with pulmonary hypertension or unstable cardiac conditions. To further characterize risks, the manufacturers agreed to perform postmarketing studies in the outpatient setting, a retrospective study in the critically ill and a pulmonary hemodynamic study.