In 2012, the Food and Drug Administration recalled Naturalyte and GranuFlo, which are manufactured by Frensenius Medical Care. Naturalyte and GranuFlo are used in the treatment of acute and chronic renal failure during hemodialysis. They are made to be used with a three-stream hemodialysis machine.
The reason for the recall? Frensenius cautioned doctors about the concentration of sodium discetate in the products because an inappropriate prescription could lead to high serum bicarbonate level in patients who are undergoing dialysis.
In simpler terms, this means during the dialysis process, biocarbonate is used to neutralize the acid that has built up in the patient’s blood. GranuFlo and Naturalyte contain an ingredient that converts into bicarbonate, and they contain more than other products on the market. However, some doctors did not account for the extra bicarbonate when determining how much bicarbonate should be prescribed separately. This essentially could result in a bicarbonate overdose.
The FDA recall states that an inappropriate prescription could lead to high levels of bicarbonate, which can contribute to metabolic alkalosis. This is a significant risk factor that is associated with the following:
High blood pressure
Hypokalemia (low potassium levels)
Hypoxemia (low blood oxygen)
Hypercapnia (high concentration of carbon dioxide in the blood)
Cardiac arrhythmia (irregular heartbeat)
According to a memo from Fresenius, 941 patients suffered cardiac arrest inside its clinics in 2010. It concluded that the high bicarbonate levels created about six times the risk of cardiac arrest.