As a Corpus Christi Texas Granuflo lawyer, I am closely following the recent developments of this medical product. GranuFlo and Naturalyte are the most widely prescribed dry acid products currently being used in dialysis. Granuflo is a powder which has an ingredient which the body converts into bicarbonate. Essentially, bicarbonate is a chemical buffer which keeps the blood from becoming either to acidic or to basic. Because lots of doctors were not warned and did not know of the higher levels of bicarbonate present in the patient’s bloodstream, these doctors did not take the higher levels into account when they prescribed additional bicarbonate. This bicarbonate overdose has unfortunately caused a 6 to 8 fold increase in cardiac arrest, heart attack, and other severe and catastrophic cardiovascular injuries.
Naturalyte and Granuflo lawyers know that these products are used when treating chronic renal failure during hemodialysis. The Naturalyte and Granuflo concentrate is formulated to be used with a hemodialysis machine. This machine is calibrated for both acid and bicarbonate concentrates.
The maker of GranuFlo and NaturaLyte, Fresenius Medical Care, is currently under investigation by the United States Food and Drug Administration ("FDA") over these heart attacks and other cardiac injuries which are associated with GranuFlo and NaturaLyte.
The FDA has received complaints detailing various alkali dosing errors which occurred during hemodialysis. When metabolized, acetic acid and acetate, which are potential sources of alkali, may contribute to very elevated bicarbonate levels in the persons undergoing hemodialysis. This may cause or contribute to metabolic alkalosis, an extremely significant risk factor for :
•Sudden heart attacks
•Hemodialysis cardiopulmonary arrest, and
•Low blood pressure
In fact, a 2010 study determined that patients with pre-dialysis bicarbonate levels higher than 28mEq/L were 4.7 times more likely to have cardiac arrest. This 2010 study also determined that patients who had pre-dialysis potassium lower than 4 mEq/L had an amazing 6.3 times higher risk of cardiac arrest.
In May 2012 the U.S. FDA informed doctors and other health care providers that consideration must be placed on the presence and amount of acetate, citrate, and acetic acid in dialysate concentrates when ordering a patient’s dialysate prescription.
In June 2012 a recall was issued by Fresenius Medical Care North America, noting the potential for "high serum bicarbonate level in patients undergoing hemodialysis."
Interestingly, in November 2011, Fresenius sent an internal memo to physicians working in the company’s dialysis centers, warning them that the failure to properly use GranuFlo appeared to be causing a big increase in patients dying suddenly from cardiac arrest. However, despite these known risks, Fresenius failed to give any type of warning to its patient clinics until March of 2012.
If you or a loved one has had a heart attack, cardiopulmonary arrest, cardiovascular death, sudden cardiac death, or any other catastrophic cardiovascular death within 24 hours of dialysis treatment, contact Texas NaturaLyte and GranuFlo lawyer Scott Nelson. Mr. Nelson serves clients throughout Texas and the United States.