Off-Label Use of Ultrasound Contrast Agents for Intravenous Applications in Children

2016 ◽  
Vol 35 (3) ◽  
pp. 487-496 ◽  
Author(s):  
Elsa Rosado ◽  
Michael Riccabona
Keyword(s):  
Contrast Agents ◽  
Ultrasound Contrast Agents ◽  
Off Label Use ◽  
Off Label ◽  
Ultrasound Contrast ◽  
Label Use

Off-label use of contrast agents

2008 ◽  
Vol 18 (6) ◽  
pp. 1096-1101 ◽  
Author(s):  
P. Reimer ◽  
R. Vosshenrich
Keyword(s):  
Contrast Agents ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Update on the safety and efficacy of commercial ultrasound contrast agents in cardiac applications

2015 ◽  
Vol 2 (2) ◽  
pp. R55-R62 ◽  
Author(s):  
Andrew W Appis ◽  
Melissa J Tracy ◽  
Steven B Feinstein
Keyword(s):  
Contrast Agents ◽  
Ultrasound Contrast Agents ◽  
Safety And Efficacy ◽  
Off Label ◽  
Ultrasound Contrast ◽  
The Us ◽  
Safety Studies ◽  
Post Marketing ◽  
Marketing Data ◽  
Ultrasound Applications

Ultrasound contrast agents (UCAs) are currently used throughout the world in both clinical and research settings. The concept of contrast-enhanced ultrasound imaging originated in the late 1960s, and the first commercially available agents were initially developed in the 1980s. Today's microbubbles are designed for greater utility and are used for both approved and off-label indications. In October 2007, the US Food and Drug Administration (FDA) imposed additional product label warnings that included serious cardiopulmonary reactions, several new disease-state contraindications, and a mandated 30 min post-procedure monitoring period for the agents Optison and Definity. These additional warnings were prompted by reports of cardiopulmonary reactions that were temporally related but were not clearly attributable to these UCAs. Subsequent published reports over the following months established not only the safety but also the improved efficacy of clinical ultrasound applications with UCAs. The FDA consequently updated the product labeling in June 2008 and reduced contraindications, although it continued to monitor select patients. In addition, a post-marketing program was proposed to the sponsors for a series of safety studies to further assess the risk of UCAs. Then in October 2011, the FDA leadership further downgraded the warnings after hearing the results of the post-marketing data, which revealed continued safety and improved efficacy. The present review focuses on the use of UCAs in today's clinical practice, including the approved indications, a variety of off-label uses, and the most recent data, which affirms the safety and efficacy of UCAs.

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

2011 ◽  
Vol 117 (1) ◽  
pp. 148-159 ◽  
Author(s):  
F. Esposito ◽  
M. Di Serafino ◽  
P. Sgambati ◽  
F. Mercogliano ◽  
L. Tarantino ◽  
...  
Keyword(s):  
Contrast Media ◽  
Off Label Use ◽  
Regulatory Requirements ◽  
Off Label ◽  
Ultrasound Contrast ◽  
Paediatric Patients ◽  
Ultrasound Contrast Media ◽  
Label Use

Indikationsfremde Anwendung von Medikamenten und Medizinprodukten in der Notfallmedizin

2019 ◽  
Vol 14 (04) ◽  
pp. 361-371
Author(s):  
Karl Peter Ittner ◽  
Joachim Koppenberg ◽  
Ute Walter
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use

ZusammenfassungWenn zugelassene Arzneimittel außerhalb der in der entsprechenden Fachinformation dargelegten Beschreibungen angewendet werden, dann spricht man von einer nicht zulassungskonformen Anwendung oder von einem Off-Label-Use. Wie in fast allen medizinischen Fachgebieten gibt es auch im Rettungsdienst sogenannte Off-Label-Use-Pharmakotherapien. Sofern evidenzbasierte Informationen zu einer nicht zulassungskonformen Anwendung vorliegen, und insbesondere im konkreten Notfall keine zulassungskonforme Möglichkeit besteht, dann ist diese gerechtfertigt. Verwendet ein Notarzt aber ein Medizinprodukt außerhalb der Zulassung, dann stellt er ein neues Produkt her und haftet persönlich bei einem Patientenschaden.

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