Fresenius Medical GranuFlo Dialysis Treatment Recall
Attorneys are currently pursuing potential lawsuits for individuals who have experienced injury or loss due to cardiovascular death, sudden cardiac death, cardiopulmonary arrest, heart attack, and other catastrophic cardiovascular injuries after being administered GranuFlo during recent dialysis treatments.
The GranuFlo Dry Acid Concentrate is used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
Fresenius Medical Care, the maker of GranuFlo is currently facing investigation by the U.S. Food and Drug Administration over heart attack and other cardiac events risks associated with GranuFlo.
Dialysis is a procedure that clears toxic waste from the blood in patients whose kidneys have failed. In dialysis, bicarbonate is administered to neutralize the acid that builds up in the blood.
Fresenius Medical Care’s GranuFlo contains an ingredient that the converts to bicarbonate at higher levels than its rival products. This may cause dangerous bicarbonate levels in patients.
What is the problem?
Fresenius manufactures two products used in dialysis, GranuFlo and NaturaLyte. Both of these dialysis products have been linked to causing alkalosis, a condition associated with an increase in cardiovascular events.
The FDA received complaints describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.
This can contribute to metabolic alkalosis, which is a significant risk factor associated with:
- Low blood pressure
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden heart attack
- Hemodialysis cardiopulmonary arrest
A study which was conducted between January and December of 2010 found that patients with pre-dialysis bicarbonate levels greater than 28mEq/L were 4.7 times more likely to suffer a cardiac arrest. The study also discovered that patients with pre-dialysis potassium lower than 4 mEq/L had a 6.3 times higher risk of cardiac arrest.
In May 2012 the FDA notified health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription.
GranuFlo Class 1 Recall
In late June 2012 a class 1 recall was issued by Fresenius Medical Care North America where they stated the reason for the recall as follows:
"The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' Naturalyte Liquid and GranuFlo Dry Acid Concentrate. 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 FDA also issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.
Serial numbers for recalled GranuFlo (powder) Acid Concentrate range from:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B
Failure to Warn
In November of 2011, Fresenius medical sent an internal memo to doctors who practiced in the company’s dialysis centers, warning them that failure to properly use GranuFlo appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. The memo also stated “In light of these troubling findings, doctors should take corrective action." “This issue needs to be addressed urgently,” the memo added later.
Despite these risks, Fresenius Medical failed to issue any type of warning to its customer clinics until March 2012. It only did so after the FDA received a copy of the company’s internal memo from an anonymous source and contacted Fresenius Medical to inquire about it.
GranuFlo & NaturaLyte is one of the most widely prescribed dry acid products in the dialysis industry today and is used at Fresenius' own clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius Medical Care. It is estimated that roughly 125,000 patients in non-Fresenius clinics are treated with GranuFlo.
GranuFlo Might Cause Heart Attack Side Effects
GranuFlo contains more bicarbonate than other dialysates, and a June 2012 New York Times article describes Fresenius’s knowledge of the risks posed by its product’s high bicarbonate level. According to the article, Fresenius sent a memo to its clinics warning that the higher bicarbonate levels in GranuFlo had caused 941 heart attacks in the company’s own clinics in 2010, leading the company’s researchers to estimate that GranuFlo increases a patient’s risk of heart attack by six times. Fresenius did not send the memo to GranuFlo-using clinics that the company didn’t own, however, and the FDA consequently began investigating Fresenius for possible violations of federal regulations, the Times reports.
In late May 2012 the FDA issued a medical device safety communication advising doctors and other health care professionals to monitor their dialysis patients closely since dialysates can contain more alkaline chemicals (acetate, acetic acid, and citrates) than they might expect.
The result of excessive alkalines in the bloodstream can lead to metabolic alkalosis, a dangerous condition that can cause the following symptoms and side effects:
- Low blood pressure;
- Hypokalemia – low potassium in the blood, which the heart and other muscles require to function properly;
- Hypoxemia – low levels of oxygen in the blood;
- Hypercapnia – excessive carbon dioxide in the blood;
- Cardiac arrhythmia – irregular heartbeat; and
- Cardiopulmonary arrest.
How Potential Overdosing Can Occur
Other acid concentrate products consist primarily of acetic acid, but GranuFlo and NaturaLyte contain acetic acid plus sodium acetate, (sodium diacetate). Sodium acetate gets converted into bicarbonate by the patient’s tissues/liver, effectively increasing bicarbonate levels beyond what was initially prescribed.
This makes correct acid and bicarbonate levels absolutely essential. Incorrectly mixed dialysate that results in increased bicarbonate levels can place patients at an increased risk of metabolic alkalosis—a dangerous GranuFlo side effect.
Note, GranuFlo and NaturaLyte are not inherently dangerous products, but become dangerous pharmaceuticals when errors occur in their mixing and administering.
A Bicarbonate Overdose: Who’s Most at Risk?
Findings behind the recent Class 1 recall of GranuFlo® and NaturaLyte® point to the dialysis risks of metabolic alkalosis—or high bicarbonate levels. Here’s more:
- Both GranuFlo and NaturaLyte contain sodium diacetate, which increases bicarbonate beyond the prescribed levels.
- Metabolic alkalosis, or high bicarbonate levels, can cause heart attack, cardiac arrest, stroke, low blood pressure and even death.
- All patients who are undergoing treatment have higher dialysis risks when using GranuFlo and NaturaLyte, though some patients are even more susceptible to elevated bicarbonate levels—causing a bicarbonate overdose.
Diabetic Patients - Diabetics, already vulnerable to a number of dialysis risks, are more likely to suffer cardiac arrest and heart failure from both increased bicarbonate levels and low concentrations of homoarginine. Having a poor tolerance to dialysis can complicate glycemic control by affecting the secretion, clearance, and peripheral tissue sensitivity of insulin. Coupling this with the fact that patients with diabetes can also suffer from additional medical issues such as hypertension, autonomic neuropathy, vasculopathy, metabolic disorders (ketoacidosis, poor glycaemic control), and electrolyte disorder—add further dialysis risks to this group.
Patients with Elevated Bicarbonate Levels - Patients who start dialysis with elevated bicarbonate levels are more at risk of further increased bicarbonate levels resulting from improperly mixed dialysate. Such patients include those with Cushing's syndrome, Conn's syndrome, Chronic Obstructive Pulmonary Disease (COPD) and other lung diseases, cardiovascular disease and those with hormone disorders.
Patients with History of Diuretics or Steroid Use - Individuals with a history of prolonged use of diuretics, laxatives or steroid also can have greater dialysis risks because of their higher bicarbonate levels before starting dialysis. Some medications and natural supplements can also increase bicarbonate levels.
Proper Ways to Avoid a Bicarbonate Overdose
Before starting dialysis, a doctor should carefully formulate a specific dialysate prescription for each individual patient.
Acetate in GranuFlo can raise levels of bicarbonate above what was originally prescribed. For example, if a prescribed dialysate calls for total buffer level* of 33 mEq/L, a clinician can easily mistake this for a total bicarbonate level of 33 mEq/L.
Clinics using GranuFlo or NaturaLyte are more likely to error because they contain a second source of bicarbonate (via acetate) that needs to be accounted for when formulating each patient’s dialysate.
Legal Help for Victims of Fresenius GranuFlo
If you have or are currently taking GranuFlo you could be at risk. You need to contact a GranuFlo attorney for a case evaluation. If you are entitled to compensation, they will ensure that you get the help you need.