Granuflo® and Naturalyte® are manufactured by Fresenius Medical Care, which is the largest national operator of kidney dialysis centers in the United States. Granuflo® is a dialysis medication which comes in the form of a powder and Naturalyte® comes in liquid form to treat acute renal failure and chronic kidney disease. Specific concentrates of Granuflo® and Naturalyte® used on dialysis patients caused dangerous cardiovascular side effects during “hemodialysis”, which helps to reduce acid buildup in the blood. The FDA issued a Class I recall in June 2012 stating concerns about dangerous side effects and specified Granuflo® and Naturalyte® “may cause serious adverse health consequences, including death”.
The main side effect of GranuFlo® and NaturaLyte® is an excess of bicarbonate in the bloodstream. This bicarbonate surplus can lead to deadly conditions such as metabolic alkalosis. Metabolic alkalosis causes death when the body has a pH level elevated beyond normal levels. Other side effects are: low blood pressure; low potassium blood levels (hypokalemia); low oxygen saturation (hypoxemia); irregular heartbeat (cardiac arrhythmia); heart attack (cardiac arrest); and increase in blood carbon dioxide (hypercapnia).