GranuFlo Recall and How Potential Overdosing can occur

By: Lewis Garrison

Fresenius Medical GranuFlo Dialysis Treatment Recall

HGD 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.

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.

To learn more about the recall and GranuFlo side effects, please visit our GranuFlo information page.

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Our attorneys are still here to help with your legal needs. We are now offering legal consultations by telephone or via video conferencing.

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