The Naturalyte and Granuflo recall was issued after concerns were raised that some patients might be exposed to increased serum bicarbonate levels, which could cause metabolic alkalosis. Metabolic alakosis is, in turn, linked to low blood pressure, hypokalemia, hopyxemia and cardiac arrhythmia. As such, high serum bicarbonate levels can cause serious adverse health consequences, including death.
"Health care professionals may not be aware that the dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis," the FDA warned in its May 25, 2012 safety communication.
Naturalyte and Granuflo Dry Acid Concentrate are used during hemodialysis to treat acute and chronic renal failure. They are used both at Fresenius dialysis centers and medical centers not linked to Fresenius. According to reports, Fresenius issued a warning about the risk of cardiac arrest and other heart problems linked to Naturalyte and Granuflo in November, but that memo went only to Fresenius centers. It was reportedly not sent to outside centers, despite the products being used at outside medical centers.
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This means that patients at outside medical centers could have been at unnecessary increased risk of elevated serum bicarbonate levels because their physicians would not have received the same information.
Once the FDA received information about Granuflo and Naturalyte, the agency issued a Class 1 recall of certain lots of the products.