According to the Centers for Disease Control and Prevention, one of the two main causes of hospitalization among people on hemodialysis is cardiovascular disease. According to the National Kidney Foundation, heart disease is the major cause of death for all people with chronic kidney disease.
Therefore, the last thing kidney patients need is something that can increase their risk of heart problems. Yet, according to recent reports, two dialysis products made by Fresenius Medical Care, NaturaLyte and GranuFlo, can do just that by increasing the risk of cardiovascular side effects. These products are used by thousands of kidney dialysis centers around the world, but it was not until a few months ago that we learned how dangerous they may be.
NaturaLyte and GranuFlo Advertised as Superior Products
According to an article in the New York Times, Fresenius treats more than a third of the estimated 400,000 Americans receiving dialysis. It is also the leading provider of dialysis machines and disposable products, which are used in Fresenius’ own clinics, but also in thousands of others.
NaturaLyte and GranuFlo are concentrates used during hemodialysis procedures to help reduce acid buildup in the blood. Both NaturaLyte and GranuFlo are advertised on Fresenius’ website as providing certain benefits over other concentrates, including less frequent and severe hypoglycemic episodes, less fatigue, and potentially lower mortality risk.
According to a November 4, 2011 company memo – which was anonymously leaked to the FDA in 2012 – these concentrates have been linked with severe cardiovascular side effects in patients.
Company Study Indicates Potential for Elevated Bicarbonate
Fresenius conducted a case-control study, examining the data from 941 patients who died of cardiopulmonary arrest in various Fresenius dialysis facilities in 2010. The company found that patients with elevated levels of bicarbonate in their blood were more at risk of death than those with normal levels of bicarbonate.
The company went on to note that many facilities had converted to the Fresenius powdered GranuFlo formulation. This product has the tendency to raise bicarbonate levels more than other similar products, because it has different levels of sodium acetate and acetic acid. Doctors were unaware of the difference, and failed to make adjustments, subjecting many patients to excess bicarbonate.
FDA Warns of Dialysis Dosing Errors
On March 29, 2012, in response to questions by the FDA, Fresenius issued a broader alert to medical centers and nursing homes, noting that patients with high bicarbonate levels were more at risk for cardiac arrest and death. Too much bicarbonate in the blood creates a pH imbalance, leading to metabolic alkalosis. Metabolic alkalosis is a significant risk factor for low blood pressure, low blood oxygen, heart rhythm problems, and sudden cardiac arrest.
The FDA followed up with its own warning on May 25, 2012, telling doctors about the dosing errors that had been reported and urging them to double-check the labels on these products before using them on patients. Many kidney patients take bicarbonate outside of dialysis, which can contribute to higher bicarbonate levels and unintentional overdose.
Class 1 GranuFlo and NaturaLyte Recall
On June 27, 2012, the FDA issued a Class I Recall notice for Fresenius Medical Care NaturaLyte Liquid and GranuFlo powder acid concentrates. The recall noted that inappropriate prescription of these products can lead to high blood levels of bicarbonate in patients going through hemodialysis. They added that this can lead to metabolic alkalosis, a significant risk factor for cardiac side effects and cardiopulmonary arrest.
The FDA recommended that healthcare providers review the concentrate labeling for each product they prescribe to determine the patient’s overall bicarbonate levels. They added that metabolic alkalosis has been associated with higher risk of death in hemodialysis patients.
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