September 9, 2010 By MATTHEW PERRONE , AP Business Writer
(AP) -- Federal health regulators are warning doctors that a class of injectable drugs used in MRI medical imaging scans can cause a rare and sometimes fatal condition in patients with kidney disease.
The Food and Drug Administration said Thursday it is adding its strongest warning label to imaging agents that contain the chemical gadolinium, indicating they should not be used in patients with kidney problems.
"These label changes are intended to help ensure these drugs are used appropriately," the FDA said in a posting to its website. The warning language will appear in a bolded box at the top of the drugs' labels.
The agency said in a statement that use of the drugs can lead to a rare syndrome that causes hardening of the skin and tissue growth along joints, eyes and internal organs. The ailment, which is sometimes fatal, is called nephrogenic fibrosing dermopathy and has been reported in patients with weakened kidney function.
There is no known treatment for the condition, though kidney transplant appears to slow disease and even reverse it in some cases.
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