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July 11, 2007

Bayer HealthCare Pharmaceuticals report on Magnevist use in NSF victims

As of May 31, 2007, Bayer HealthCare Pharmaceuticals and its parent company have received 78 reports where patients purportedly developed NSF following Magnevist administration, and all these reports have been filed with the Health Authorities. Onset of NSF signs and symptoms in the reports dates back up to several years, and the time span between the administration of MR contrast medium and the occurrence of signs and symptoms ranges between several days and several years. In terms of standardized causality assessments, 27 of the 78 reports have been assessed as "possibly" related to the administration of Magnevist; 46 have been assessed as "unclassifiable" since currently available information is not sufficient to verify the diagnosis of NSF by deep skin biopsy and histopathology and/or to link the cases exclusively to the administration of Magnevist; and 5 have been assessed as "unlikely" to be related to the administration of Magnevist.

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