What is GranuFlo?
GranuFlo Dry Acid Concentrate is a chemical used in hemodialysis treatment that was created by Fresenius Medical Care, one of the largest providers of dialysis products and services in the world. During dialysis, a patient with end-stage kidney failure has their blood removed and mechanically cleaned. This process normally increases the acidity of the blood. GranuFlo is used along with a bicarbonate concentrate and liquid to balance the acidity of blood to the body’s normal pH (7.35 – 7.45).
What is the problem?
Unlike other acid concentrate products, which contain primarily acetic acid, GranuFlo contains a combination of acetic acid and sodium acetate. When these chemicals pass through a patient’s liver, a small percentage is metabolized into bicarbonate. Doctors must adjust the dose to adjust for this “extra” bicarbonate in GranuFlo. If they do not, the patient may overdose on bicarbonate. This causes a life-threatening condition called metabolic alkalosis, in which the blood has a very low pH.
Failure to Warn About GranuFlo Risks
In June 2012, the New York Times reported that Fresenius was under investigation from the FDA for failing to warn about deadly side effects of GranuFlo. In November 2011, Fresenius sent an internal memo to doctors at the company’s medical centers, warning them that incorrect doses of GranuFlo appeared to be contributing to a sharp increase in patient deaths due to cardiac arrest.
The memo indicated that 941 patients died inside 667 Fresenius clinics in 2010, and those who had high pre-dialysis bicarbonate levels were 6- to 8-times more likely to suffer cardiopulmonary arrest. This risk information was not disclosed to the FDA or doctors at non-Fresenius clinics who were using GranuFlo.
In March 2012, Fresenius and the FDA issued a Class I GranuFlo recall, which is the most urgent type of recall. The FDA warned:
“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.”
GranuFlo Side Effects
- Cardiopulmonary arrest
- Heart attack
- Cardiac arrest
- Low blood pressure
- Metabolic alkalosis
- Low potassium (hypokalemia)
- Low oxygen (hypoxemia)
- High carbon dioxide (hypercapnia)
- Irregular heart rhythm (cardiac arrhythmia)
Do I have a GranuFlo Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in GranuFlo lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free GranuFlo Lawsuit Evaluation: Again, if you or a loved one was injured by GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a GranuFlo lawsuit or by joining a GranuFlo class action lawsuit and we can help.