FDA Ignored Data on Risky MRI Dye
Failed to single out role of GE dye, Omniscan, in onset of disease
By Kevin Spak,  Newser Staff
Posted Oct 16, 2009 8:51 AM CDT
A General Electric Co. plant is seen, Saturday, May 12, 2007, in Lynn, Mass.   (AP Photo/Lisa Poole)
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(Newser) – In May 2006, Danish medical regulators came to GE with troubling findings. Twenty-five patients with weak kidneys had developed NSF, a rare and sometimes fatal disease, after undergoing MRIs, and all 25 had been injected with GE’s Omniscan dye. Since then, the GE dye, along with other so-called “contrast agents” has been tied to many more cases, with Omniscan playing a disproportionate role. Of the 400 US lawsuits over NSF, 300 involve Omniscan.

But when the FDA looked into the phenomenon in 2007, it issued a blanket “black box” warning on all contrast agents, ignoring the findings of two of its doctors—reported for the first time now by Pro Publica—that Omniscan was riskier, and should be contraindicated. GE claimed that it had simply been more diligent in reporting cases, and the FDA ultimately ruled that it didn’t have enough data. One imaging safety expert now calls that decision “inappropriate and indefensible.”