Definition - What does Granuflo mean?
Granuflo is a kidney dialysis additive that was first introduced to the market in 2003 by Fresenius Medical Care North America (FMCNA). Granuflo is a dialysate, which is a dry acid additive containing sodium diacetatein. Granuflo contains certain chemicals that can be converted in a patient’s body to form bicarbonate, which can potentially slow chronic kidney disease.
Unfortunately, the Federal Drug Administration (FDA) has received reports that certain patients taking Granuflo have not sufficiently monitored their pre-dialysis bicarbonate levels, which may increase the risk of cardiac events during or immediately following dialysis.
Although Granuflo has helped many patients, some users claim Granuflo may have been introduced to the market without sufficient warnings from Fresenius Medical Care. Specifically, claimants have filed product injury claims against Fresenius Medical Care claiming the company did not provide enough information about how to use the Granuflo additive and how to sufficiently adjust the amounts of Granuflo for patients with elevated pre-dialysis bicarbonate levels.
Justipedia explains Granuflo
Claimants allege that when patients with elevated pre-dialysis bicarbonate levels were given Granuflo they may have experienced high levels of serum bicarbonate, leading to metabolic alkalosis.
Bicarbonate is critical to neutralize acidity in the body and restore the body’s pH balance. Healthy kidneys produce a sufficient amount of bicarbonate to maintain the body’s pH balance.
Unhealthy kidneys, however, do not produce sufficient bicarbonate, allowing for excess acid to build up in the body, leading to acidosis. Patients with failing kidneys must undergo dialysis, which restores the blood to its normal levels by removing fluids, toxins and wastes.
Granuflo works in conjunction with the hemodialysis and dialyzer machines to increase bicarbonate concentration levels for patients undergoing dialysis.
Claimants in lawsuits against Fresenius Medical Care allege that when patients with elevated pre-dialysis bicarbonate levels were given Granuflo, they may have experienced high levels of serum bicarbonate, leading to metabolic alkalosis. This condition can be especially dangerous and can cause other serious health conditions such as heart attacks, cardiopulmonary arrest, and sudden cardiac death.