Become a Cardiac Imaging Insider! When AuntMinnie gets hot new information on Cardiac Imaging, Cardiac Imaging Insiders are the first to find out. Receive exclusive e-mail updates on your favorite new technologies and get techniques for staying current in today's competitive radiology market. Become a Cardiac Imaging Insider, and get the inside scoop first!
Atlas of Cardiovascular Computed Tomography The Atlas of Cardiovascular Computed Tomography is a comprehensive atlas containing photomicrographs, anatomic illustrations, tables, and charts paired ... Price: $99.00 Click here
Practical Handbook of Advanced Interventional Cardiology, 3rd Edition Price: $99.95 Click here
Clinical Echocardiography Price: $140.00 Click here
More study of heart imaging agent risks urged By Reuters Health June 25, 2008
SILVER SPRING, Maryland (Reuters), Jun 25 - Makers of contrast agents used to enhance echocardiograms need to conduct larger studies to better evaluate the heart risks seen in some patients, a U.S. panel of medical experts said on Tuesday.
The Food and Drug Administration (FDA) imposed warnings late last year on imaging agents made by General Electric's GE Healthcare and Lantheus Medical Imaging after receiving 200 reports of complications, including seven deaths.
But the agency relaxed the restrictions earlier this year, to allow somewhat wider use, after doctors said the agents gave them life-saving information.
"It's not that a drug or a test agent is without risk. It's that I need to understand the risk," said William Hiatt, a medical professor at the University of Colorado in Denver who chaired the panel.
The FDA's director of medical imaging products, Dwaine Rieves, told the panel that the agency wanted advice on what safety issues to consider as companies seek to use imaging agents to diagnose other conditions such as liver problems.
Ideally, the panel of experts said, companies either already selling or seeking to market such agents would conduct a randomized placebo-controlled study of thousands of patients, but they could also conduct observational studies.
GE Healthcare, maker of Optison, and Lantheus, whose product is Definity, have already agreed to review postmarketing data for safety issues, but Rieves told reporters after the meeting that the panel's recommendations could affect the advice given to companies seeking future FDA approvals.
Representatives for GE Healthcare and Lantheus as well as Bracco Diagnostic, which sells its SonoVue contrast agent in Europe, told panelists the agents are safe and noted that many patients given the agents are already very sick.
"There were no safety concerns ... in the safety studies we investigated," said Steven Feinstein, a professor at Rush University Medical Center in Chicago, who spoke on behalf of GE Healthcare. The company returned Optison to the U.S. market in late 2007, two years after manufacturing woes brought it off the market.
Various physicians speaking to the panel urged further study but said medical information gleaned with contrast agents outweighed their side effects.
"The black box warning has had a significant deterrent effect," said William Zoghbi, president of the American Society of Echocardiography (ASE), which estimates about 22 million heart ultrasounds were conducted in the United States in 2005.
He urged the companies and the FDA to collect more data to better determine which patients are at risk and eliminate the warnings.
By Susan Heavey
Last Updated: 2008-06-25 12:49:10 -0400 (Reuters Health)
SILVER SPRING, Maryland (Reuters), Jun 25 - Makers of contrast agents used to enhance echocardiograms need to conduct larger studies to better evaluate the heart risks seen in some patients, a U.S. panel of medical experts said on Tuesday.
||