Two dialysis drugs have been recalled; GranuFlo and Naturalyte

GranuFlo and Naturalyte are two dialysis products recalled by the Food and Drug Administration. Fresenius Medical Care, the world’s largest provider of dialysis clinics and products, manufactures both GranuFlo and Naturalyte. The FDA has issued a Class 1 recall – the most urgent type of recall – on both products. This recall is reserved for situations that lead or could possibly lead to death. These two drugs are leading to severe complications and increasing the risk of death.

GranuFlo and Naturalyte are dialysate acid concentrates. These products are used during dialysis, which is the process of mechanically removing toxins from the blood of patients with kidney failure. During dialysis, bicarbonate is administered to neutralize the acidity that naturally builds up in the blood. In addition to the bicarbonate, GranuFlo and Naturalyte neutralize acid in the bloodstream. Many people, including health care professionals, are unaware of the ingredients in these products that convert to bicarbonate in the body. GranuFlo and Naturalyte consist of acetic acid plus acetate. This is what is being converted to bicarbonate by the patients’ livers. This can lead to an increased risk of a bicarbonate overdose, metabolic alkalosis and death.

In November 2011, Fresenius Medical Care sent an internal memo to physicians working in dialysis centers owned by the company. This memo stated potential side effects associated with elevated bicarbonate levels in the blood caused by these products. The memo also included the fact that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving dialysis treatment with GranuFlo and Naturalyte. FMC’s studies found that patients undergoing dialysis treatments with these products are six times more likely to suffer from a heart attack or sudden cardiac death. The manufacturer of these products did also notify facilities that are not owned by FMC.

On May 25, 2012 the FDA made the following warning about the risk of GranuFlo and Naturalyte:

“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which if not appropriately treated may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

The New York Times
gives more information on the warning.

GranuFlo and Naturalyte side effects include heart attack, low blood pressure, myocardial infarction, stroke, metabolic alkalosis and cardiopulmonary arrest. More information on side effects can be found here. If you or a loved one had GranuFlo or Naturalyte dialysis treatment and are having these side effects, please consult your doctor. It is important to know what is being injected in a patient’s body. Many drugs have side effects, however those associate with GranuFlo and Naturalyte are extremely severe. Everyone deserves justice. Do not let a situation like this go unnoticed.

Please call us for a free consultation.
Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB