Fresenius Medical Care’s (FMC) dialysis concentrate – GranuFlo – has been linked to a condition known as metabolic alkalosis. Metabolic alkalosis is a condition in which the body accumulates too much of an alkaline substance like bicarbonate. Elevated alkaline levels make it difficult for the body to produce enough acid to neutralize the effects of alkali and patients with unbalanced levels of acid and alkaline may begin to show symptoms of metabolic alkalosis.

Symptoms of Metabolic Alkalosis

One of the first symptoms of metabolic alkalosis can be slowed breathing. Individuals suffering from metabolic alkalosis may also have episodes of apnea (not breathing), develop a bluish or purplish discoloration of the skin, and feel nausea, irritable, and confused. Other symptoms of metabolic alkalosis are: irregular heart beat, drop in blood pressure, and rapid heart rate.

If recognized early and treated promptly, people with mild cases of metabolic alkalosis usually do not suffer long-term complications, however, severe cases of metabolic alkalosis can lead to convulsions, coma, cardiac arrest, and death.

GranuFlo Dialysis Concentrate

GranuFlo is the most prescribed dry acid concentrate used in hemodialysis (process of filtering blood through a machine outside of the body). Reportedly, in early 2010, FMC became aware of a significant risk of cardiac arrest and death associated with the use of GranuFlo. Although GranuFlo is used globally in both FMC owned dialysis clinics and non-FMC clinics, FMC only notified doctors working in their clinics of the risks linked to the company’s dialysis concentrate. It wasn’t until the Food and Drug Administration launched an investigation to determine whether or not the company violated federal regulations in March 2012 that FMC warned non-FMC dialysis clinics of the potentially life threatening side effects linked to GranuFlo.

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