The FDA recently issued a Class I recall for Naturalyte GranuFlo and Naturalyte Liquid Acid Concentrate made by the Fresenius Medical Care North America Company on June 27, 2012. The recall was issued by the FDA because the products may lead to a high level of serum bicarbonate in patients undergoing hemodialysis.
The Fresenius Medical Care North America Company is the nation’s largest operator of dialysis centers. More than a third of the estimated 400,000 Americans who receive dialysis get treated at one of the facilities.
According to the FDA, a high level of serum bicarbonate can contribute to metabolic alkalosis. This is a significant factor associated with hypoalemia, hypercapnia, cardiac arrhythmia, hypoxemia, and low blood pressure. These products can lead to serious health complications including death.
The Fresenius Medical Care North America Company originally discovered these serious health issues in November 4, 2011. The company failed to warn their patients using these products after conducting their own research. An internal memo written by the Fresenius Medical Care North America Company in November 2011 said: “Recent analyses preformed using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia. The major cause of metabolic alkalosis in dialysis patients is inappropriately high dialysate total buffer concentration. As recommended in previous communications, physicians should individualize dialysate bicarbonate and total buffer prescriptions. We further recommend that pre-dialysis serum bicarbonate level of >24 mEg/L should prompt immediate review of dialysate bicarbonate prescription.”
When this information and research was discovered, the Fresenius Medical Care North America Company failed to inform their patients or the FDA. The company waited unto; March 29, 2012 to publically come out with this information. The company issued a memo explaining that the two products, NaturalLyte Liquid and Granuflo powder, contain acetate and bicarbonate. They finally came out and said that reports had found elevated pre-dialysis bicarbonate levels and an increased mortality risk associated with the products. Other studies the company completed found that “using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia.” This memo also indicated that the FDA was advised of this information on that date.
Why did it take so long for the Fresenius Medical Care North America Company to come public with this crucial information? Evidence clearly shows that Fresenius knew about these risks and failed to warn their patients.
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