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Subscribe To Our Syndicated NewsFDA Claims MRI-Enhancing Agents Need Warnings
-August 3, 2007
The FDA recently announced that contrast agents used to create magnetic response imaging or MRI scans easier, should carry stronger warnings.
“Black Box” Warning
According to the FDA a “black box” warning would be beneficial in alerting health care professionals that patient's with unique kidney and liver conditions are at risk for a certain, potentially deadly disease.
The enhancing agents have been known to cause nephrogenic systemic fibrosis (NSF), a disease that causes the skin, organs and other tissues to thicken, making it hard to move and causing bones to easily break.
The new warnings seek to alert both patients and doctors that those with kidney or liver problems are at a higher risk for developing NSF.
Not the First Alert
Bayer AG's Bayer Schering Pharma, General Electric's Co's Healthcare and Bracco Diagnostics Inc. manufacture these gadolinium-based imaging agents.
FDA officials first alerted doctors of risks associated with the agents in June 2006 and again in December 2006.
The FDA says that patients should be screened for kidney problems before using the agents.
Doctors have also been told to make sure a given dose has been eliminated from the body before the agent is given again.
(Source: Reuters)
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