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In March 2012, the FDA issued a Class 1 recall notice for Granuflo (dry) and Naturalyte (liquid) acid concentrates due to the risk that improper mixtures of the products could contribute to a high serum bicarbonate level in hemodialysis patients and trigger metabolic alkolosis. This concentrate was manufactured and distributed from January 2008 through June 2012. A Class 1 recall is the most serious kind. It involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or even death.
GranuFlo is an experimental drug designed to facilitate kidney dialysis. Medical researchers learned that GranuFlo’s primary ingredient converted to bicarbonate during dialysis. Bicarbonate is a class of naturally-occurring salts, in the same chemical tree as baking soda (bicarbonate of soda). It is critical to dialysis because it neutralizes the body’s pH level, or acidity, helps kidneys function more fully and regulates the body’s acid/base balance.
Thus, while bicarbonate is essential to dialysis’s goal and health in general, too much can cause serious problems. Physicians, who did not know that GranuFlo converted to bicarbonate, sometimes gave patients too much, resulting in unexpected cardiac complications.
The graphic contains information from the U.S. Food and Drug Administration (FDA) and other sources. It provides details concerning the Class I recall notice that has been issued for these products as well as information concerning the risk of metabolic alkalosis. This is for educational purposes only.
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