GranuFlo and NaturaLyte has been linked to inducing higher than normal levels of bicarbonate. Because bicarbonate is alkaline (or basic), excessive amounts of the chemical in the bloodstream can cause metabolic alkalosis. The human blood has a very narrow pH range of 7.35 to 7.45, when the blood pH reaches anything lower or higher than those two numbers, a healthy kidney can filter out the excess bicarbonate or carbonic acid. However, for hemodialysis patients, a natural filtration is not possible, leaving patients at risk of metabolic alkalosis. Symptoms of the dangerous condition includes:
- Cardiac arrhythmias
- Low blood pressure
- Muscle pain
Complications from Metabolic Alkalosis
Maintaining homeostasis is critical for the regular function of the body. When the kidney is unable to excrete the excess bicarbonate, the blood reaches a higher than normal pH. The resulting metabolic alkalosis has been associated with a number of very serious health problems, including:
- Cardiac arrest
- Sudden cardiac death.
GranuFlo and Metabolic Alkalosis
Fresenius Medical Care (FMC) has long been the leading provider of dialysis products, from machines to acid concentrates used in dialysate solutions. Recently, FMC’s most widely used acid concentrate, GranuFlo and its liquid form counterpart, NaturaLyte have been recalled due to dangerous risks of metabolic alkalosis. Since its release in 2003, GranuFlo has been used in thousands of hemodialysis treatments, with over 3,300 dialysis centers using the dry acid concentrate. Unfortunately for the 260,000 patients who receive GranuFlo dialysis treatments a year, the metabolic alkalosis risk factors have only just been released to the public.
How GranuFlo Causes Metabolic Alkalosis
Because metabolic alkalosis is simply the build-up of bicarbonate, it can easily be avoided in renal disease patients by closely monitoring the pre-dialysis bicarbonate levels in the bloodstream. As patients with kidney failure have no functioning blood filtration capabilities of their own, any over-prescription can cause serious health problems. In the case of GranuFlo, the acetic acid and sodium acetate formula converts into bicarbonate at greater speed and percentage than formulas composed of only acetic acid. Consistent overdose overtime can have deadly consequences for patients with serious renal disease.
Delayed FDA Notice
In addition to the recall, the FDA issued a warning to all dialysis centers in regards to inappropriate prescriptions and alkali dosing errors in the dialysate. But for thousands of patients, the recall and warnings have come much too late. In 2010 alone, during the period FMC was conducting its internal case-control study, 941 patients died from cardiac arrest, possibly due to GranuFlo related bicarbonate overdose. And despite having sent an internal memo informing all of the FMC operated dialysis facilities, the FDA was not notified until March 29, 2012.
Liability for GranuFlo Related Damages
FMC continues to deny a conflict of interest, and asserts the delayed FDA notice was due a lack of sufficient evidence. But the estimated $80 million per year revenue from GranuFlo sales strongly contests those claims. Already hundreds have decided to seek financial compensation for GranuFlo and NaturaLyte related damages. If you would like to determine whether FMC may be held liable for the damages incurred as a result of metabolic alkalosis complication in a patient receiving GranuFlo dialysis treatment, contact a trusted product liability lawyer today.