Tuesday, August 10, 2010

Yet Another Study Proves Safety Of Ultrasound Contrast

I was scanning the news at Aunt Minnie this morning and noticed another study has been completed concerning the safety of ultrasound contrast.  An editorial linked with the article asked a great question: "Is the FDA listening?"  Folks it has been proven by 3 years of research that ultrasound contrast agents used here in the USA for  echocardiography are safe and effective, yet the FDA refuses to remove the black box warning on Optison and Definity.  And further more, the FDA refuses to allow Doctors to use ultrasound contrast in other imaging applications such as categorization of liver masses which has proven very useful when screening hepatitis sufferers for hepatocellular carcinoma.  It is high time the FDA stops acting like an ostrich and remove it's head from the hole in the ground. 

NEW YORK (Reuters Health), Aug 10 - Contrary to earlier concerns, using contrast agents in echocardiography does not lead to more myocardial infarctions (MIs) or deaths, a new meta-analysis has shown. 

"This analysis should put to rest the concerns about the safety of echo contrast agents. The usefulness of these agents has been shown in many studies and they should be used in these clinical situations," senior author Dr. Mouaz H. Al-Mallah told Reuters Health by e-mail.
In October 2007, based on four reported deaths after administration of an ultrasound contrast agent, the U.S. Food and Drug Administration issued a black box warning for all such agents, the researchers note in their paper. Contrast agents were specifically contraindicated in patients with acute cardiopulmonary syndromes, severe pulmonary hypertension, and QT prolongation."

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