In 2010, Fresenius Medical Care, the world’s largest provider of dialysis services and products, sent an internal memo to doctors at its clinics stating there was a significant increased risk of cardiac arrest and death in patients during hemodialysis treatments using its dialysates product GranuFlo.
GranuFlo contains an ingredient that metabolizes in the body into a substance known as bicarbonate.
Elevated levels of bicarbonate contribute to metabolic alkalosis, which is a significant risk factor for cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. GranuFlo contains more of the bicarbonate-making ingredient than competitor products, but the labeling on the package appears to have been misleading doctors. The New York Times had an interesting story on the time line last year.
Fresenius only informed doctors in its clinics, not patients or health care professionals at other clinics who purchased the product. However, an anonymous source tipped off the Food and Drug Administration (FDA), which conducted an investigation . Fresenius later informed patients and other clinics of the problem, and recalled its products to change instructions on the label.
The company is currently facing numerous lawsuits from patients and their family members who suffered cardiac arrest after being given GranuFlo and a similar product, NaturaLyte.
The plaintiffs in those cases accuse Fresenius of not providing adequate dosing instructions for its products used during dialysis. The products contain an ingredient that converts to bicarbonate during treatment. GranuFlo and NaturaLyte contain more of this ingredient than competitor products.
People on dialysis have a hard time keeping their phosphorus levels in a healthy range. Phosphorus binders prevent the body from absorbing the phosphorus from the food one eats. High levels of phosphorus can pull calcium out of bones and weaken them. The mineral can also join with calcium and cause calcium deposits in the blood vessels, lungs, eyes and heart.
Maintaining the balance of blood chemistry is of vital importance for patients with kidney disease and especially those on dialysis. Dialysis is the process for removing waste and excess water from the blood when the kidneys are not functioning properly or have failed. During dialysis, substances are used to help clean the blood, such as dialysates. These products are prescribed in precise levels for each patient undergoing dialysis.
Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. is investigating cases involving serious injury or death of patients who received GranuFlo or NaturaLyte solutions during dialysis treatments. What do you think of Fresenius informing only its clinics and not the patients or health care professionals who purchased and used the product?