Granuflo and NaturaLyte are widely used in the treatment of acute and chronic renal failure. Chronic renal failure is often caused by diabetes or low blood pressure. Acute renal failure occurs when the kidneys suddenly stop functioning. Chronic kidney failure affects about 2 million people worldwide. In the United States, kidney disease affects more than 2 out of every 1,000 people.
People with kidney conditions encounter Granuflo – a powdered product – or NaturaLyte – the liquid version of GranuFlo during a dialysis treatment called hemodialysis. This is a three- or four-hour process in which the blood is removed from the body, sent through a filter to remove harmful substances and then returned to the body. Hemodialysis, which is typically performed three times a week, accomplishes what unhealthy kidneys cannot.
A dialysis machine, called a dialyzer, uses a special solution called dialysate to clean the blood. Dialysate is a mixture of water and chemicals, and dosing is based on blood tests and how patients react to treatment. The three-stream hemodialysis machines must be properly calibrated to account for the bicarbonate concentrate that is part of the dialysate. Bicarbonate is an alkaline substance used to neutralize acid buildup in the blood. GranuFlo and NaturaLyte contain acetate and sodium diacetate as active ingredients that produce bicarbonate during hemodialysis.
There are concerns, however, that the ingredients may produce an excess of bicarbonate. Too much bicarbonate can lead to complications such as metabolic alkalosis, a condition in which the pH level in the body is elevated.Metabolic alkalosis can lead to low blood pressure, cardiac arrhythmia (irregular heartbeat), cardiac arrest, hypokalemia (lowered potassium in blood), hypoxemia (lowered oxygen in the blood), hypercapnia (increased carbon dioxide in the blood) and death.
|Symptoms of metabolic alkalosis include:|
|Numbness or tingling|
People with too much bicarbonate in their blood have six times the risk of cardiac arrest as those with lower levels.
Fresenius Medical Care, GranuFlo and NaturaLyte
GranuFlo, which was approved by the U.S. Food and Drug Administration (FDA) in 2003, and NaturaLyte are both manufactured and marketed by the German company Fresenius Medical Care (FMC). The company, which in 2011 had net revenue of $12.8 billion, is the leading supplier of dialysis machines and disposable products, and dominates the U.S. dialysis market. Several times every week, 400,000 Americans with kidney disease undergo dialysis, a life-saving process that filters the blood. More than half of these patients use GranuFlo or NaturaLyte.
FMC also has clinics that perform dialysis, and the company uses its products during these treatments. It treats nearly 138,000 kidney patients in its more than 1,800 U.S. dialysis clinics. And an estimated 125,000 patients are treated with GranuFlo at other clinics.
However, FMC is facing mounting lawsuits after reports surfaced that 941 patients suffered cardiac arrest in 2010 after using GranuFlo at one of its clinics. In March 2012, the U.S. Food and Drug Administration recalled GranuFlo and NaturaLyte to clarify dosing guidelines, but the recall came too late for an untold number of patients who lost their lives after using the products.
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FMC Memo and FDA Recall
On Nov. 4, 2011, the North American office of FMC sent out a six-page internal memo to doctors using GranuFlo and NaturaLyte in FMC clinics, informing them that 941 patients using these products had suffered cardiac arrest in 2010. The memo came with guidelines for physicians to follow and specified that the products could increase the risk of cardiac arrest during dialysis by six to eight times, if dosing was incorrect. Other clinics using FMC products were not notified.
That same month, at the annual meeting of the American Society of Nephrology, one presentation highlighted the problem of higher bicarbonate levels and increased mortality. The presentation examined evidence from a study of 16,899 patients and found that the high bicarbonate levels could result in a risk of metabolic alkalosis, which could be fatal. They concluded that this risk deserved further study.
In fact, FMC officials had been aware of the bicarbonate dangers when the solutions were originally approved in 2003, but did not inform clinics, patients or the FDA. On March 27, 2012, the FDA and sent the company an inquiry regarding the alkalosis side effects, which provoked a two-page Urgent Product Notification to non-FMC clinics, alerting them of the dangers and guidelines. Two days later, the FDA issued a Class I recall for NaturaLyte and GranuFlo products manufactured between January 2008 and June 2012 and used in three-stream hemodialysis machines.
Class 1 recalls involve the possibility of adverse health reactions, including death, and are the most serious type of recall. The FDA recall did not necessitate removal of FMC’s products from clinics, only the addition of proper dosing procedures and label updates. The recall also alerted physicians about the dangers of inaccurate dosing.
On May 25, 2012, the FDA sent out a safety communication, advising nephrologists, dialysis nurses and technicians to correctly administer dialysate concentrate. There was also a recommendation that physicians be aware that levels of these substances vary by product and manufacturer.
GranuFlo and NaturaLyte Lawsuits
Hundreds of people who have either suffered from side effects associated with GranuFlo and NaturaLyte or who have lost loved ones who used these dialysis products have filed lawsuits against FMC. They say they were not properly warned about the dangers associated with dialysis treatment.
Betty Lemmond, from Alabama, lost her husband, Dizzy, who received dialysis treatment at an FMC clinic for a couple of months before he suffered a fatal heart attack. Waddell Bishop filed a lawsuit over the death of his mother, Frances, after dialysis treatment. Both of these suits, as well as countless others, include counts of wrongful death. More cases are expected to be filed in the coming months.