FDA MedWatch - Update on MRI Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy

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>http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gadolinium Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance Audience: Radiologists, Nephrologists, Dermatologists and other healthcare professionals[uPDATED 12/22/2006] FDA notified healthcare professionals that the Agency received a total of 69 case reports of patients with moderate to end-stage renal disease who underwent magnetic resonance imaging or magnetic resonance angiography and developed Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). These reports provide more evidence for a causal relationship between gadolinium-based contrast agents and the development of NSF/NFD.

[Posted 06/08/2006] FDA notified healthcare professionals and consumers that it is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan, a gadolinium-containing contrast agent, and took the MRA test. The FDA is gathering additional information about NSF/NFD and is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD and whether other patients who received gadolinium-containing contrast agents developed NSF/NFD. FDA has not yet

determined whether exposure by patients with kidney failure to these products during an MRA test causes NSF/NFD. The FDA urges health care providers and patients to report adverse event information to the FDA online at http://www.fda.gov/medwatch/report.htm, by phone (1-800-FDA-1088) or by fax (1-800-FDA-0178).[December 22, 2006 - Drug Information Page - FDA] [June 08, 2006 - Public Health Advisory - FDA] [June 08, 2006 - Public Health Advisory - FDA] [June 06, 2006 - "Dear Healthcare Professional" letter - GE Healthcare]