About the Granuflo & Naturalyte Dialysis Recall

GranuFlo and NaturaLyte are substances used for dialysis to reduce the effect of the acid that develops in the blood of dialysis patients. The medications were manufactured by Fresenius Medical and distributed to almost 2,000 dialysis facilities. These popular dry acid products were recalled by the Food and Drug Administration (FDA) in March of 2012, as they were determined to have caused serious health consequences or death. The FDA recalled the drugs due to severe cardiac risks and a link to metabolic alkalosis, which triggers cardiac arrhythmia, hypercapnia, hypoxemia, hypokalemia, and low blood pressure. If metabolic alkalosis is not properly treated, it can lead to cardiac arrest and death.

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Data taken from Fresenius showed that there was an increase in heart attacks and cardiac arrest incidents after having dialysis with GranuFlo and NaturaLyte. This increase was four to six times the number of incidents prior to using GranuFlo and NaturaLyte. The company did not notify the FDA or doctors of the incidents. Fresenius knew about the data, but it did not do anything about the conditions. When the FDA discovered the data, it was concerned that Fresenius had not informed doctors and dialysis centers that GranuFlo and NaturaLyte caused a quick rise in the number of deaths linked to cardiac arrest after dialysis. Fresenius executives retorted that the company did not have a way to warn doctors and clinics.

Currently, over 500,000 Americans use dialysis in the treatment of kidney disease, and there are almost 6,000 dialysis centers located in the United States. 260,000 patients on dialysis have been prescribed GranuFlo and NaturaLyte, and over 125,000 individuals have been approved for the drugs utilized at a dialysis clinic that is not owned by Fresenius. Approximately 4,700 patients had a cardiac arrest after dialysis linked to GranuFlo during 2010.

GranuFlo and NaturaLyte were both recalled because of the high levels of bicarbonate that were found in individuals who had used the products. The high level of bicarbonate in a person’s body can cause severe and possibly fatal cardiac arrest. Several lawsuits have been filed as a result of this recall.