GranuFlo and NaturaLyte

GranuFlo and NaturaLyte are medications used during dialysis to treat acute renal failure and chronic kidney disease. Frequent dosing errors with the medications may have caused serious complications in multiple dialysis patients including:

• Hypoxia
• Metabolic alkalosis
• Cardiac arrhythmia
• Cardiac arrest
• Death

The FDA issued a Class I recall of GranuFlo and NaturaLyte in 2012 and manufacturer, Fresenius Medical Care has been accused of failure to notify the FDA and doctors about the dangers of the medications.

Jump to topic
  • What is GranuFlo?
  • What is NaturaLyte?
  • What Is Dialysis?
  • Who uses Granuflo and NaturaLyte?
  • What are the Side Effects of GranuFlo?
  • What is Alkalosis?
  • What are the Complications of Alkalosis?
  • Was GranuFlo Recalled?
  • Was the GranuFlo Recall Delayed?
  • GranuFlo Lawsuits

What is GranuFlo?

GranuFlo is citrasate dry acid concentrate which contains both acetic acid and sodium citrate. It is a “dry acid concentrate” in powdered form that is reconstituted and used to treat acute renal failure and chronic kidney disease as a chemical component of kidney dialysis.

GranuFlo received approval from the U.S. Food and Drug Administration (FDA) in 2003. Its manufacturer, Fresenius Medical Care (FMC), dominates the dialysis market in the United States. In 2011, FMC netted $12.8 billion in revenue from its disposable products and dialysis machines.

What is NaturaLyte?

NaturaLyte is a similar medication but comes in liquid form as liquid hemodialysate concentrate, rather than powder. It is formulated to be used in a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

What Is Dialysis?

During dialysis treatment, a patient’s blood is removed, filtered of harmful substances, then returned to the body. The kidney is typically responsible for this filtration process. However, kidney disease and renal failure render the kidneys incapable of performing this essential function.

During the dialysis process, a solution called dialysate is used to clean the patient’s blood. Bicarbonate is an important substance in the dialysate solution. GranuFlo contains acetate and sodium diacetate, which produce bicarbonate. Many dialysis machines today are three-stream. This means that they mix dialysate using bicarbonate, filtered water, and acid concentrate.

When the process is complete, the filtered blood is returned to the body, along with additional bicarbonate. It is important that the dialysis machines are properly calibrated in order to account for the bicarbonate already present in the GranuFlo dialysate solution.

Who uses Granuflo and NaturaLyte?

Roughly 400,000 Americans who suffer kidney disease undergo dialysis treatment to filter their blood several times each week. Of these 400,000, it is estimated that nearly half use GranuFlo or its liquid counterpart NaturaLyte. A large number of these GranuFlo treatments are administered in Fresenius Medical Care clinics, but many are also used in other dialysis clinics.

Because of the concentrated nature of both GranuFlo and NaturaLyte, many dosing errors have occurred in both FMC and non-FMC clinics. Patients who are given incorrect dosages are six to eight times more likely to suffer cardiac arrest. FMC now faces mounting lawsuits for death and injury resulting from the use of GranuFlo and NaturaLyte.

What are the Side Effects of GranuFlo?

Under normal conditions, when given appropriately, GranuFlo and NaturaLyte will not cause side effects other than symptoms normally experienced as part of the dialysis process.

However, when dosing is not accurate, the major side effect of GranuFlo and NaturaLyte is an excess of bicarbonate in the bloodstream. This bicarbonate surplus can lead to potentially deadly conditions, including metabolic alkalosis.

What is Alkalosis?

Metabolic alkalosis occurs when the body’s pH level is too high or elevated beyond a normal level. In some cases, these heightened bicarbonate levels can lead to death.

What are the Complications of Alkalosis?

Excess bicarbonate from GranuFlo can also cause:

  • Low blood pressure
  • Cardiac arrhythmia, or irregular heartbeat
  • Hypoxemia, or lowered blood oxygen
  • Hypokalemia, or lowered blood potassium
  • Hypercapnia, or increased blood carbon dioxide
  • Cardiac arrest

Was GranuFlo Recalled?

In March of 2012, a Class I recall was issued by the U.S. Food and Drug Administration for GranuFlo and NaturaLyte products that were manufactured from January 2008 and June 2012 that were used in three-stream dialysis machines.

A Class I recall is the most serious FDA recall. It alerts the public of adverse health reactions and possible death. The recall did not require that GranuFlo and NaturaLyte were removed from clinics. Instead, it required that proper dosing procedures and label updates be implemented. The recall also warned doctors of inaccurate dosage dangers.

Was the GranuFlo Recall Delayed?

In November 2001, FMC’s North American office sent out an internal memo to doctors who used GranuFlo and NaturaLyte in FMC’s dialysis clinics. This memo notified doctors that in 2010, 941 patients suffered cardiac arrest from GranuFlo and NaturaLyte use. Additionally, the memo outlined specific guidelines for physicians when administering GranuFlo and NaturaLyte. Unfortunately, FMC did not send this memo to non-FMC clinics.

In March 2012, the FDA sent an inquiry to FMC regarding the side effects of alkalosis. Shortly afterward, an Urgent Product Notification was sent to non-FMC clinics. The FDA then issues a Class I recall for GranuFlo and NaturaLyte

GranuFlo Lawsuits

A number of GranuFlo and NaturaLyte lawsuits have been filed. Many of these cases involve the death of a loved one from using these dialysis products. Plaintiffs claim that consumers were not adequately warned of the dangers of using GranuFlo and NaturaLyte. It is recommended that victims of these FMC dialysis products immediately seek a qualified and experienced attorney. An attorney can help discuss legal options and file a claim.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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