NaturaLyte and GranuFlo Dialysis Side Effects
On June 27, 2012, the FDA issued a Class I NaturaLyte and GranuFlo recall, notifying physicians and dialysis patients that these products may cause serious adverse health consequences, including death.
Products used to control acid buildup during hemodialysis procedures, GranuFlo and NaturaLyte were made differently than previous concentrate products, and therefore had the potential to dangerously elevate bicarbonate levels. High levels of bicarbonate in the blood can cause serious NaturaLyte and GranuFlo side effects, including heart rhythm disorders, heart attack and sudden death.
Patients bringing claims against manufacturer Fresenius Medical Care argue the company did not provide adequate warnings on the product labels about the health risks, and should be held liable for medical expenses, lost wages, pain and suffering, and in some cases, wrongful death.
The human body constantly produces acids, which are usually excreted by the kidneys. When the kidneys are malfunctioning, as they are in dialysis patients, they are unable to maintain a proper pH balance in the body. This leads to an acidic atmosphere, called acidosis.
To counteract this acid buildup, patients with kidney disease take regular medications to alkalize the blood. During dialysis, in which the blood is cleaned of toxins and waste by a machine, they are also treated by a neutralizing or buffering solution that controls excess acid.
One of the key components used in alkalizing the blood is called “bicarbonate,” which is a naturally occurring salt in the body. Considered the most important buffer in preventing the blood from becoming too acidic, it is normally secreted by the stomach, but in the kidney patient, it must be added to the body, as well.
During hemodialysis, the patient gets bicarbonate from two sources:
- The bicarbonate concentrate used during the hemodialysis procedure
- The acetate in the acid concentrate (such as GranuFlo or NaturaLyte)— which is quickly converted in the liver to bicarbonate
Dialysis side effects from excess bicarbonates
During the dialysis procedure, the physician or technician must perform due diligence in monitoring a patient’s bicarbonate levels. Too little means the blood will become too acidic, which can lead to shock or death. Too much means the blood will become too alkaline, which can lead to heart rhythm problems and heart attack.
The technician must be careful as the value of bicarbonate indicated on the dialysis machine is only from the carbonate concentrate, and does not include the additional bicarbonate that is produced in the liver from the acetate in the concentrate solution.
When Fresenius made these products, they created a unique formulation that doctors were unfamiliar with. These formulas use sodium diacetate, rather than just acetate, which actually doubles the amount of acetate in the solution, compared to standard formulations.
These new formulas increased the amount of bicarbonate in the blood of dialysis patients, and if the doctors were not aware of this difference, they could administer the improper dose, causing dangerously elevated levels of bicarbonate – and life-threatening NaturaLyte and GranuFlo side effects.
Plaintiffs who have filed a GranuFlo lawsuit against Fresenius claim the company did not do enough to train doctors, nurses, and technicians about the uniqueness of their formulas, leaving them uneducated about the dosage adjustments they needed to implement.
NaturaLyte and GranuFlo side effects
When bicarbonate levels become elevated in the blood, they create a condition known as metabolic alkalosis, which is the opposite of acidosis.
Alkalosis is associated with the following complications and dialysis side effects:
- Hypokalemia (imbalanced electrolyte levels)
- Low potassium levels
- Low blood pressure
- Low blood oxygen
- Excess blood carbon dioxide
- Respiratory failure
- Impaired organ function
- Arrhythmia, or irregular heartbeat
- GranuFlo heart attack
Fresenius notes risk of dialysis injury
On November 4, 2011, Fresenius Medical Care issued an internal memo to all of their dialysis centers. In the memo, they reported on a case-control study they conducted on 941 patients who died of heart attack between January 1 and December 31, 2010 in their facilities, presumably as a result of dialysis side effects.
They found through their analysis that high levels of bicarbonate in the blood was an independent risk factor for complications like heart attack, and advised doctors to be more aware of a patient’s bicarbonate levels before beginning dialysis.
They also noted that “Many facilities have converted to the Fresenius powdered ‘GranuFlo’ formulation,” and stated some physicians had failed to adjust the dosage “when shifting to the power concentrate, thus exposing patients to a higher total buffer load than intended.”
FDA investigates reports of GranuFlo related heart attacks
On June 14, 2012, the New York Times reported that the FDA was investigating Fresenius Medical Care, to determine whether they violated federal regulations by failing to inform customers of a potentially lethal risk connected to its products, GranuFlo and NaturaLyte.
The FDA received an anonymous copy of the Fresenius 2011 memo in 2012. Only when they asked the company about the document did Fresenius issue a second memo on March 19, 2012, warning medical directors and health care providers outside of the Fresenius network who also used these products.
Those who have filed claims against Fresenius contend that the manufacturer should have warned all medical centers using GranuFlo and NaturaLyte as early as possible, rather than leaving patients at risk of GranuFlo side effects. Not only were thousands of dialysis physicians unaware of the risks between November and March—when only Fresenius dialysis centers had been warned about the potential problems—but prior to that, when the company received increasing reports of heart attack and sudden dialysis death among patients who were administered improper doses of its products.
FDA Recall & Warning of GranuFlo dialysis side effects
On March 29, 2012, the FDA issued the Class I GranuFlo recall, noting that inappropriate use of GranuFlo and NaturaLyte could lead to alkalosis and serious dialysis side effects, including heart attack. Meanwhile, patients who had been injured or lost loved ones from these products were encouraged to talk to legal counsel about their rights.
On May 25, 2012, the FDA issued another safety communication cautioning physicians about the potential dosing errors that could occur with GranuFlo and NaturaLyte. The agency noted they had received complaints describing errors that occurred with dialysate concentrates containing acetic acid and acetate. They recommended doctors be aware that metabolic alkalosis was associated with a higher risk of death in hemodialysis patients.
- FDA Safety Communication, Dialysate Concentrates and Alkali dosing errors with hemodialysis (May 25, 2012) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305477.htm
- New York Times, Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry (June 14, 2012) http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=1&
- FDA Class 1 NaturaLyte & GranuFlo Recall http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm
- Fresenius Medical Care, Update on Dialysate Labeling http://www.fmc-ag.com/4410.htm