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FDALive.com

GE Suit Hushes Scientist Critical of Omniscan

by Jeff Gerth, ProPublica, and Jon Ungoed-Thomas, The Sunday Times - December 19, 2009 4:00 pm EST

Henrik Thomsen, a Danish radiologist who is credited as one of the clinicians who alerted patients and regulators to the potential risks of Omniscan for renal patients, refuses to speak anywhere in England on the possible risks of Omniscan. The reason is that he faces another kind of storm: GE Healthcare is suing him for libel in the UK High Court. Read More »

Major Stories

FDA Advised to Tighten Restrictions on GE and Covidien MRI Drugs

by Jeff Gerth, ProPublica - December 9, 2009 3:35 pm EST

An FDA advisory panel recommends effectively banning the use of GE’s Omniscan and Covidien’s Optimark in patients with severe kidney disease.

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FDA to Take a Second Look at Warnings on MRI Drugs

by Jeff Gerth, ProPublica - October 16, 2009 2:37 pm EST

After issuing a blanket warning about the risk to patients with kidney disease, regulators will reconsider whether to treat some imaging agents differently.

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Feds May Tighten Rules on Omniscan, a GE MRI Drug

by Jeff Gerth, ProPublica - December 2, 2009 5:55 pm EST

An FDA review says MRI imaging drugs may be even riskier for kidney patients than it believed previously.

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Specter of MRI Disease Haunts GE

by Jeff Gerth, ProPublica - October 15, 2009 4:16 pm EST

Many MRI patients are injected with a GE dye to enhance images. If they have weak kidneys, they might develop a rare and sometimes fatal disease

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GE and Omniscan

Omniscan is one of General Electric’s contrast agents, which are drugs administered by radiologists to improve the visibility of a patient’s internal body structure. It is estimated by regulators to have 30 percent of the U.S. market. Roughly 300 of the 400-plus lawsuits filed by those who suffer from Nephrogenic Systemic Fibrosis concern Omniscan.

Nephrogenic Systemic Fibrosis (NSF) is a potentially fatal disease that is characterized by painful swelling and thickening of the skin. There is no known cure or definitive cause for NSF, though it appears to affect only MRI patients who have kidney problems.

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How Three Hospitals Handled Omniscan

The Doctors' Viewpoints

While GE argued against special restrictions on Omniscan, doctors at three U.S. medical centers moved away from the agent of their own accord. See More »

Multimedia

Video: Celeste Castillo Lee on Suffering From Nephrogenic Systemic Fibrosis (Video copyright FDALive.com.)


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