GranuFlo Dialysis Lawsuit Lawyer
Please note: Our law firm no longer accepts Granuflo cases.
GranuFlo, used in dialysis, appears to increase the risk of heart attack. On March 29, 2012, all Fresenius Medical Care (FMC) Granuflo dialysates products were the subject of a class I FDA recall, which included all products made since 2008. The FDA is also investigating whether the company’s failure to warn patients violated federal law. It appears now that Fresenius Medical Care (FMC) failed to alert the public to the GranuFlo heart attack risk for several months after first discovering the increased heart attack risk.
What is GranuFlo?
Two of every 1,000 Americans suffer chronic kidney failure. People whose kidneys fail to filter blood must undergo hemodialysis. In this procedure a machine removes toxins and waste from the blood, then returns it to the body. GranuFlo powder concentrate and its liquid counterpart, NaturaLyte, are drugs called dialysates, and are central to the dialysis process. Health-care professionals use dialysates in dialysis machines to neutralize the natural buildup of acid in the blood.
More than 900 Heart Attacks
GranuFlo problems first surfaced in 2010 when more than 900 people suffered heart attacks while receiving treatment in Fresenius Medical Care clinics. A powder concentrate used during dialysis to help patients with kidney failure remove toxins from the blood, GranuFlo is mixed with bicarbonate to neutralize the acid. However, GranuFlo already contains higher levels of bicarbonate than its competitors’ products, so the addition of extra bicarbonate can lead to a fatal overdose for the patient. Research suggests that excessive levels of bicarbonate increase the risk of heart attack six-fold.
FDA: FMC Dosing Errors
GranuFlo has been linked to alkalosis, a serious condition known to increase potentially perilous cardiovascular events.
The FDA has received complaints describing alkali dosing errors that occurred during hemodialysis which used dialysate concentrates containing acetic acid and acetate. These potential sources of alkali – when metabolized – can contribute to elevated bicarbonate levels in patients undergoing hemodialysis, which can lead to metabolic alkalosis.
Metabolic alkalosis is a significant risk factor associated with several potentially life-threatening health problems:
- Low blood pressure
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden heart attack
- Stroke
- Hemodialysis cardiopulmonary arrest
