GranuFlo or NaturaLyte case

NaturaLyte and GranuFlo, used in dialysis, appear to increase the risk of heart attack. On March 29, 2012, all Fresenius Medical Care (FMC) Naturalyte and Granuflo dialysates products were the subject of a class I FDA recall, which included all products manufactured since 2008. The FDA is also investigating whether the company’s failure to warn patients violated federal law. It appears now that Fresenius Medical Care (FMC) failed to alert the public to the GranuFlo heart attack risk for several months after first discovering the increased heart attack risk.

“Dear Doctor” Letter too little too late

In a “dear doctor letter” issued the same day as the recall, FMC advised care providers that dialysates do contain acid units, with emphasis on prescribing accurate units of acids in preparing final buffer solutions. And yet FMC failed to inform the prescribing physicians of the real problem, which is the very chemical nature of Sodium diacetate. The use of Sodium diacetate is not problematic; but failing to expressly inform prescribers that it yields two acid units is.

A full six months before the recall, FMC had warned its own dialysis centers and doctors about the use of incorrect units of acids, but they did not warn other centers and physicians who use Naturalyte and GranuFlo products. They only did so when forced six months later by the class I recall of their products.  It is not yet clear whether FMC had a legal obligation to notify other customers; but that apparent obligation is currently being evaluated by FDA. We  think it’s clear FMC  had a moral and fiduciary duty to do so.  It appears the company placed profits ahead of patient safety.

More than 900 Heart Attacks

GranuFlo problems first surfaced in 2010 when more than 900 people suffered heart attacks while receiving treatment in Fresenius Medical Care clinics. A powder concentrate used during dialysis to help patients with kidney failure remove toxins from the blood, GranuFlo is mixed with bicarbonate to neutralize the acid. However, GranuFlo already contains higher levels of bicarbonate than its competitors’ products, so the addition of extra bicarbonate can lead to a fatal overdose for the patient. Research suggests that excessive levels of bicarbonate increase the risk of heart attack six-fold.

Hemodialysis Patients Need Perfect Balance

Patients suffering from acute and chronic kidney disorder often must rely on dialysis and hemodialysis to have the toxic byproducts removed from their system.  To these patients dialysis treatment is a matter of life or death.

Hemodialysis buffered solution must achieve a final balanced acid/base buffer.  As with bicarbonate units, the number of acid units are displayed on the product label and disclosed with more detail in product datasheet (acid in dialysate is measured in milliequivalent in volume expressed as mEq/L).    Achieving a perfect balance of acid and base in the final hemodialysis solution is of paramount importance.  Too much bicarbonate in patient’s system destroys the electrolyte balance and can rapidly lead to metabolic Alkalosis, a significant risk factor associated with cardiopulmonary arrest and other cardiac and circulatory problems with high mortality.  Adding the correct number of acid units in preparation is critical since acid units are rapidly metabolized in the liver to yield additional bicarbonate in the system.

FMC & Socium diacetate

Fresenius Medical Care North America (FMCNA) is the largest dialysis medical care related company in the U.S.. It manufactures Naturalyte liquid acid and Granuflo powder acid dialysate products.  FMC is also the largest operator of dialysis centers in the U.S.   Unlike other dialysates, FMC products contain Sodium diacetate, which is different from acetic acid and citric acid used in other dialysates.  Each unit of Sodium diacetate is a 1:1 mixture of one Sodium acetate and one acetic acid.   Consequently, using 1 unit of Sodium diacetate supplies 2 units of acids to the final hemodialysis solution  Obviously, sodium diacetate, if not accounted for accordingly, can significantly increase the amount of bicarbonate delivered to the patient compared to acetic or citric based products.

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