WASHINGTON — The Food and Drug Administration is warning doctors that a class of injectable drugs used in MRI scans can cause a rare and sometimes fatal condition in patients with kidney disease.
The FDA is adding its strongest warning label to medical imaging agents that contain the chemical gadolinium, indicating they should not be used in patients with kidney problems.
The agency said use of the drugs can lead to hardening of the skin and tissue growth along joints, eyes, and internal organs. The ailment, sometimes fatal, is called nephrogenic fibrosing dermopathy and has been reported in patients with weakened kidney function.
There is no known treatment, though a kidney transplant appears to slow the disease and even reverse it in some cases.
Known as contrast agents, the products are used to improve clarity in scans of organs. The FDA has approved five such agents since 1988.
While the syndrome has been reported with all five drugs, the FDA said three have greater risks than the others: Bayer Healthcare’s Magnevist, General Electric Healthcare’s Omniscan, and Covidien’s Optimark.
The new FDA labels instruct physicians to screen patients for kidney disease before administering the agents. The FDA said there haven’t been any reports of the syndrome in patients with normal kidney function.
