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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

(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.”

A General Electric Co. plant is seen, Saturday, May 12, 2007, in Lynn, Mass. (AP Photo/Lisa Poole)

An MRI scan. (AP Photo)

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COMMENTS

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Showing 3 of 5 comments

PhillytoWinnetka

Oct 17, 2009 5:11 AM CDT

No matter how you slice it..pharma is in the business to make profit and no doubt lines get blurred...just like what happened w/ tobacco companies. Buyer beware.

Jes

Oct 16, 2009 5:53 AM CDT

@DLY: You're probably one of those people who claims they've gotten the flu from the flu shot before also, right?

davjc09

Oct 16, 2009 4:41 AM CDT

@dontlikeyou: We've been making flu vaccines the same way for 30 years. Only very minute things change in the actual vaccine and that's because the influenza virus changes it's surface proteins every year. Do your own research before you just regurgitate whatever Beck wants you to believe.

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FDA Ignored Data on Risky MRI Dye

Failed to single out role of GE dye, Omniscan, in onset of disease

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FDA • General Electric • MRI • Food and Drug Administration • medical technology • Omniscan

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Group of employees files lawsuit

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FDA sites badly trained staff, poor record-keeping

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They can help smokers quit, but anti-smoking groups still want ban

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Big Tobacco was likely to win First Amendment complaint

FDA Doctored Its Gross Cigarette Photos

That's one way to counter tobacco company lies!

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FDA Ignored Data on Risky MRI Dye

Failed to single out role of GE dye, Omniscan, in onset of disease

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OTHER STORIES ON OUR RADAR

FDA • General Electric • MRI • Food and Drug Administration • medical technology • Omniscan

MOST POPULAR STORIES

[ By Views ]

[ By Comments ]

More Newser Stories

FDA Whistleblowers: Our Email Was Monitored

Group of employees files lawsuit

Feds Hit Red Cross With $9.6M Fine

FDA sites badly trained staff, poor record-keeping

E-Cigs Work, But Have Smoking Foes Burning

They can help smokers quit, but anti-smoking groups still want ban

Judge Blocks Gruesome Cigarette Labels

Big Tobacco was likely to win First Amendment complaint

FDA Doctored Its Gross Cigarette Photos

That's one way to counter tobacco company lies!

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Newser By Users

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What is Newser?