GranuFlo and NaturaLyte Overview
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:
• Metabolic alkalosis
• Cardiac arrhythmia
• Cardiac arrest
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.
What Is GranuFlo?
GranuFlo is citrasate dry acid concentrate used in in dialysis treatments for patients with renal failure or kidney disease. It which contains both acetic acid and sodium citrate. It is a “dry acid concentrate” which contains both acetic acid and sodium citrate in powdered form that is reconstituted before use.
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 a liquid citrasate concentrate, similar to GranuFlo and intended to be used in dialysis. Like GranuFlo, it also contains both acetic acid and sodium citrate and is diluted to be used in the fluid exchange process of kidney dialysis. It is formulated to be used in a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Who Makes GranuFlo?
Both GranuFlo and NaturaLyte are manufactured by Fresenius Medical Care (FMC) North America. FMC is a primary supplier of dialysis machines and products, and also operates hundreds of dialysis clinics around the United States.
Fresenius products like GranuFlo and NaturaLyte are used in FMC clinics, but also in other stand-alone or healthcare system-operated dialysis clinics that are not associated with Fresenius.
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.
Granuflo and NaturaLyte in Fresenius Medical Clinics
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.
Granuflo Side Effects
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.
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.
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
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.
GranuFlo and NaturaLyte were administered through dialysis treatments in thousands of medical facilities. These facilities included third-party hospitals and clinics, as well as clinics owned and operated by Fresenius.
In November 2011, Fresenius had issued an urgent internal company memo to Fresenius clinics administering GranuFlo and NaturaLyte. The memo reported that 941 Fresenius clinic patients suffered heart attacks. The memos linked an excess level of blood bicarbonate with significantly increased the risk of cardiac arrest and outlined specific guidelines for physicians when administering GranuFlo and NaturaLyte.
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. However, Fresenius did not notify the FDA or distribute the memo to medical professionals outside of the Fresenius corporation.
In March 2012, the memo was anonymously leaked to the FDA and the Agency sent an inquiry to FMC regarding the side effects of alkalosis. In defense, Fresenius stated that the information had not been reported to the FDA as it was too preliminary for public release.
The FDA immediately launched an investigation and later sent an Urgent Product Notification was sent to non-FMC clinics. The FDA then issued a Class I recall for GranuFlo and NaturaLyte
Multiple GranuFlo lawsuits were filed against Fresenius Medical Care and against individual dialysis clinics. The GranuFlo and NaturaLyte lawsuits claimed that patients suffered serious health complications as a direct result of using the medications, in most cases due to a high risk of dosing errors.
GranuFlo and NaturaLyte dosing error can cause metabolic alkalosis which may lead to conditions such as hypoxemia, hypokalemia, hypercapnia, and cardiac arrhythmia. GranuFlo lawsuits alleged that despite knowledge of side effects and dosing errors, Fresenius continued to market and sell the drug without properly warning doctors and patients of the risks.
Injuries claimed in lawsuits included:
- Metabolic alkalosis
- High bicarbonate levels
- Low potassium levels
- Low oxygen levels
- Low blood pressure
- High carbon dioxide levels
- Cardiac arrhythmia
- Heart attack
Additionally, plaintiffs alleged that Fresenius deliberately misled consumers regarding the safety of GranuFlo. Fresenius is accused of displaying a “conscious disregard” for the public’s safety in favor of sales and revenue.
GranuFlo Lawsuit Settlements
In 2013, federal GranuFlo and NaturaLyte cases were consolidated into a multidistrict litigation (MDL) in the U.S. District Court, District of Massachusetts. The number of cases ultimately reached more than 4,000.
In February 2016, Fresenius Medical Care offered a $250 million settlement for members of the MDL, some of whom agreed to settle. Other plaintiffs declined to settle and continued in their lawsuits.
FMC won a state lawsuit in Massachusetts and in 2017, won the first of the bellwether trials but in 2018, a federal jury awarded $383 million to families of three patients who had died after GranuFlo treatment.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.