GranuFlo, a dialysis drug manufactured by German-based Fresenius Medical Care, has been linked to sudden cardiac arrest and death. On November 4, 2011 Fresenius sent out an internal memo warning that failure to account for an excess of bicarbonate resulting from an ingredient contained in their product, GranuFlo, was associated with “… 6 to 8 fold greater risk of CP arrest and sudden cardiac death in the dialysis facility.” Fresenius Medical Care is the nation’s largest operator of dialysis centers (treating more than one third of all Americans receiving dialysis), the leading supplier of dialysis machines and disposable products, and the manufacturer of the dialysis drugs GranuFlo and NaturaLyte.
Though Fresenius stated in the internal memo to its own dialysis centers that “this issue needs to be addressed urgently;” they apparently did not see the need to warn other centers of the dangerous findings on their product. The FDA is currently investigating just why Fresenius Medical Care chose not to share their findings with their customers and other centers that use their product, and whether their failure to inform others of the potentially lethal risk of one of their products is a violation of federal regulations. The FDA only learned of the findings in March 2012, after it received a copy of the internal memo anonymously.
The memo stated the findings that 941 patients suffered cardiac arrest inside Fresenius clinics in 2010. Dr. Franklin W. Maddux, chief medical officer for Fresenius North America stated that his office had no way of communicating with non-company clinics other than through medical journals saying that he did not feel the memo was “… in a condition for general consumption.” Perhaps the difficulty in distributing the message that GranuFlo use is associated with increased bicarbonate levels and alkalosis, and the increased risk of cardiopulmonary arrest had something to do with the fact that, since its introduction in 2003, GranuFlo has steadily increased in market share and is now used by the majority of approximately 400,000 kidney dialysis patients in the US, resulting in massive profits for Fresenius.
“The facts that have come to light in this case clearly demonstrate that Fresenius has known for years that GranuFlo/NaturaLyte products increase the risk of sudden death in dialysis patients. The information in their hands was not communicated to the public until they were forced by the FDA. We may not ever know how many deaths could have been prevented but, tragically, it’s a very large number,” says Chris Paulos, attorney with Levin, Papantonio.