FDA Finalizes Boxed Warning on Gadolinium Due to Adverse Reaction

September 28, 2007--The Food and Drug Administration has just finalized its request to Bayer AG's Bayer Schering Pharma, General Electric Co's GE Healthcare, Tyco International Ltd's Mallinckrodt unit and Bracco Diagnostics Inc., all of which manufacture Gadolinium-based contrast dyes used for MRIs.

Due to the growing incidences reported of people with pre-existing kidney disease who develop a debilitating skin reaction after having MRIs with gadolinium agents, The FDA has ordered that its most stringent warning, the so-called "black box," be added to the labels of all Gadolinium products used for MRIs.

Some kidney patients who have been injected with gadolinium have developed Nephrogenic Systemic Fibrosis, which triggers thickening of the skin, organs and other tissues.

This condition, in turn, makes it difficult to move and can lead to broken bones.

To date, there is no effective treatment.

If you have developed Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy following an MRI/MRA, you deserve the guidance of a lawyer experienced in such cases. Please complete the form below for a free legal evaluation.

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see also:

FDA Responds FDA Notifies Doctors and Patients on Gadolinium in MRI Procedures
FDA Responds to Reports of NSF/NFD Related to Gadolinium in MRI Tests

FDA FAQs FDA Q&A: Information on Gadolinium Enhancement to Contrast Agents
Questions and Answers on Gadolinium Enhancement to MRI Dyes--FDA Info

FDA Warnings FDA Requests Boxed Warning for Gadolinium Dye Used with MRIs
FDA Warning: "Black Box" to Be Placed on MRI Dyes with Gadolinium