An estimated 20 million Americans have weakened kidney function, putting them at risk for kidney failure. Once kidneys fail, people are forced to undergo dialysis treatment. GranuFlo is a powder concentrate used during dialysis treatments. After it hit the market in 2003, it became one of the best-selling concentrates for dialysis treatment. But when internal documents showing the product could cause serious side effects surfaced, affected patients fought back with lawsuits. Learn more about GranuFlo, how and why its used and the potentially fatal risks associated with it.
What is GranuFlo?
GranuFlo is a dry acid concentrate used in dialysis treatments. GranuFlo is one part of a three-part solution that helps clean the blood of patients on dialysis.
What is dialysis?
When a person’s kidneys stop working properly, he or she may start a certain treatment called dialysis. Dialysis replaces the work the kidneys used to do. In 2013, over 466,000 people were undergoing some sort of dialysis treatment, according to the National Institutes of Health.
The kidneys play an essential role in the body. They clean the blood by removing extra fluid, waste and toxins, which are then eliminated from the body through urination.
If the kidneys become damaged, those extra wastes and toxins can build up in the body and cause serious health risks if not treated. Diabetes and high blood pressure are two of the most common causes of kidney damage and, ultimately, kidney failure.
Aside from a kidney transplant, dialysis is the only way to keep a person alive when his or her kidneys fail. There are two types of dialysis treatments, hemodialysis and peritoneal dialysis.
Hemodialysis
During hemodialysis, blood is cleaned using a machine. Patients are connected to the machine by tubes attached to a vein and artery. Blood flows out of the patients’ bodies and into the dialysis machine where it is filtered through an artificial kidney, called a dialyzer. The dialyzer filters waste products from the blood, and the cleaned blood is then put back into the patients’ bodies.
Peritoneal dialysis
Instead of using a machine, peritoneal dialysis uses a person’s own abdominal lining to filter waste from the blood. A catheter is placed in the belly through which a sterile cleansing fluid called dialysate is pumped into the body. The dialysate filters the blood and leaves the body through the same catheter when treatment is over.
How is GranuFlo used during dialysis?
GranuFlo is one part of a three-part solution, called dialysate, used during dialysis. The dialysate cleans the blood by pulling out excess waste, such as urea, potassium and extra fluid.
Dialysate is made of three main ingredients: ultrapure water, bicarbonate concentrate and acid concentrate. GranuFlo is the acid concentrate part of the solution.
The bicarbonate concentrate helps neutralize blood pH, which can become too acidic in people with kidney failure as wastes and toxins build up in the blood. The acid concentrate helps neutralize the pH balance of the dialysate solution, while adding necessary electrolytes like sodium, potassium, calcium and magnesium.
The amount of bicarbonate and acid in the dialysate must be carefully controlled to ensure dialysis is safe and effective for patients.
When did the Food and Drug Administration approve GranuFlo?
GranuFlo received FDA approval in 2003 through the agency’s 510(k) program. GranuFlo is approved for use during hemodialysis to treat chronic and acute renal failure.
Who makes Granuflo?
GranuFlo is manufactured by Fresenius Medical Care, the largest dialysis service and product provider in the world.
Fresenius is a giant in the dialysis industry, operating its own dialysis centers around the world, manufacturing dialysis machines that make up about 50 percent of the U.S. market share, and selling dialysis products like GranuFlo. The company made over $15.8 billion in 2014.
What are the risks associated with GranuFlo?
GranuFlo has been linked to potentially life-threatening side effects. In a safety communication issued on May 25, 2012, the FDA warned about the possible adverse effects of acid concentrates used in dialysate solutions, including metabolic alkalosis and cardiac arrest.
Metabolic alkalosis
People with kidney failure often suffer from too much acid in the blood – a condition called acidosis. Some patients undergoing hemodialysis with GranuFlo solutions, however, seemed to have the opposite problem; they were presenting with too much bicarbonate in the blood, a condition that can lead to metabolic alkalosis.
Metabolic alkalosis occurs when the body’s pH goes higher than the normal range of 7.35 to 7.45. It is a potentially life-threatening condition and is a “significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia,” the FDA communication warned.
Cardiac arrest
Dialysis treatment can put patients at risk for cardiac arrest or heart attack. For patients undergoing hemodialysis, their risk for cardiac arrest is especially significant during the first two months of treatment, but that risk usually declines thereafter.
Metabolic alkalosis can also put a person at increased risk for cardiac arrest. GranuFlo is associated with a four- to six-fold increased risk of cardiac arrest if a patient’s blood bicarbonate levels are too high.
How does GranuFlo increase the risk of metabolic alkalosis and heart attack?
GranuFlo was unlike other acid concentrates on the market because it contained sodium diacetate – the powder form of liquid acetic acid used in traditional dialysates.
Sodium diacetate by its very nature (di = two) doubles the amount of acetate in acid concentrations — something physicians didn’t always take into consideration when prescribing dialysis treatments for patients.
The FDA’s May 25 communication highlighted this risk and urged health care professionals to consider the amount of acid concentrate in dialysate solutions when determining a patient’s dialysate prescription.
How can too much acid concentrate lead to metabolic alkalosis if the condition occurs when the body has too much bicarbonate in the blood? The answer is pretty simple. Acid concentrate turns into bicarbonate in the body.
Because GranuFlo contained two-times the amount of acid concentrate than traditional products, patients were at an even greater risk of metabolic acidosis. This also put patients at a greater risk for cardiac arrest because metabolic acidosis is a significant risk factor for cardiac arrest.
What are the symptoms of metabolic alkalosis?
Metabolic alkalosis is a potentially life-threatening condition that occurs when the body’s pH is too basic.
Symptoms of metabolic alkalosis may include:
- Confusion (can progress to stupor or coma)
- Hand tremor
- Light-headedness
- Muscle-twitching
- Nausea vomiting
- Numbness or tingling in the face, hands, or feet
- Prolonged muscle spasms
Has GranuFlo been recalled?
Yes. The FDA initiated a class I recall of GranuFlo on June 25, 2012. Class I recalls are the FDA’s most serious type of recall, reserved for products that pose the most serious risks to consumers, including death.
According to the FDA, GranuFlo was recalled because of the risk of alkalosis associated with the product. The agency determined the product’s label was false and misleading and all lots of GranuFlo were recalled nationwide.
The recall is still open, according to the agency’s site.
Did the makers of GranuFlo hide evidence of the drug’s risks?
In 2012, the FDA anonymously received an internal memo written by a Fresenius employee. The internal memo, dated Nov. 4, 2011, reportedly warned physicians within the Fresenius network of the increased risk of alkalosis and GranuFlo.
The memo was written after a company-led trial reportedly found a four- to six-fold increased risk of cardiac arrest in patients with high bicarbonate levels in their blood. The company, however, did not warn physicians outside its own network of this potential risk – until the FDA received a copy of the memo over a year later.
Soon after the memo was leaked, the company sent a letter to all physicians warning them of GranuFlo’s risks. A few days later, the FDA issued its May 25 safety communication and on June 25 the FDA initiated its class I recall.
Are there lawsuits against the makers of GranuFlo?
Yes. There are currently more than 4,300 lawsuits that have been consolidated in a multidistrict litigation (MDL) in federal court. Unlike a class action lawsuit, cases in an MDL are heard individually. The GranuFlo MDL was consolidated in the U.S. District Court for the District of Massachusetts with Senior District Judge Douglas P. Woodlock presiding.
The statute of limitation may be approaching soon for new cases to join the MDL, as Fresenius announced in February 2016 that it would agree to settle the cases for $250 million so long as 97 percent of plaintiffs agreed to the terms of the settlement by July 2016.
NaturaLyte, GranuFlo’s liquid counterpart also manufactured by Fresenius, is also involved in these product liability lawsuits.
I suffered a heart attack after undergoing dialysis treatment with GranuFlo. Can I file a lawsuit?
If you or a loved one suffered cardiac arrest while being treated with GranuFlo for kidney failure, you may be able entitled to compensation, but you need to act now. With the announcement from Fresenius Medical saying it agrees to pay $250 million to settle claims by July 2016, the statute of limitations may be running out.
Contact the Hood National Law Group today at 1-800-214-1010 for a free case evaluation or use the form on the right-hand side of your screen.
