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Fresenius clarifies its response to risk of alkalosis with certain dialysis solutions. |
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Nephrology News: "In this case, with respect to 'total buffer,' the Chief Medical Office distributed to FMS medical directors a working hypothesis relating to dialysate mix products in general, but also specifically citing our products Granuflo and Naturalyte, that -- pending further data collection, analysis, and development -- might or might not eventually support conclusions warranting general external or peer reviewed publication. When this circular to FMS medical directors was brought to the attention of the FDA, the agency invited a dialogue with Fresenius Medical Care in which we have been pleased to participate and that is continuing, and which encompasses ways that the kidney care community can be reminded and encouraged more aggressively to consider the implications of all sources of 'total buffer' in the dialysis process. In consultation with the FDA, we have refined our already-existing warnings and reminders about 'total buffer' connected to our products and, we anticipate, have provided a foundation for broader publication by the FDA to the entire community.
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