The International Contrast Ultrasound Society (ICUS) has filed a citizen petition with the FDA for removing the black box warning, which was first mandated by the FDA in 2007. The warning was implemented after the FDA received reports of 11 deaths that occurred between 2001 and 2007 that at the time were believed to have been related to ultrasound contrast administration.
But since then, a number of clinical studies have been published demonstrating the good safety profile of the agents. Black box warnings are typically reserved for products with the highest level of safety risk, a profile that does not fit ultrasound contrast, proponents of the technology maintain.
Indeed, the citizen petition filed by ICUS references an extensive body of favorable safety that wasn't available when the FDA first mandated the black box warnings in 2007, according to the society. Other societies supporting the petition include the American Institute of Ultrasound in Medicine, the World Federation of Ultrasound in Medicine and Biology, the Society of Radiologists in Ultrasound, the Society of Diagnostic Medical Sonography, the Society for Pediatric Radiology, the American Society of Echocardiography, and the Liver Imaging Reporting and Data System (LI-RADS) contrast-enhanced ultrasound working group. ICUS said that other individual physicians have also submitted letters in support of the petition.
ICUS had previously petitioned the FDA for the removal of the black box warnings in September 2018. Three ultrasound contrast agents -- Definity (Lantheus Medical Imaging), Lumason (Bracco Diagnostics), and Optison (GE Healthcare) -- are currently approved for use in the U.S.
The ICUS petition pointed out that the FDA has downgraded package insert contradictions three times since 2007 and removed a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiopulmonary conditions. The FDA has also recently approved new ultrasound contrast indications for adults and children, ICUS said.
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