As a Texas medical doctor and GranuFlo and NaturaLyte defective drugs injury and death attorney I am providing this timely update for folks who have been injured by dialysis from the use of GranuFlo and NaturaLyte defective drugs. Many wrongful death victims are seeking compensation for their injuries from Fresenius Medical Care (FMC), the maker of GranuFlo and NaturaLyte defective drugs.
FDA Recall of GranuFlo and NaturaLyte
Recently GranuFlo and NaturaLyte were recalled after a announcement from the U.S. Food and Drug Administration in March 2012. According to scientific studies, many patient injuries and deaths may be associated with GranuFlo and NaturaLyte used in dialysis treatments. The recall was a type Class 1, which is a class reserved for recalled products that can cause severe health problems or death.
Reason for FDA Recall
The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
GranuFlo and NaturaLyte Heart Injuries
Plaintiffs have alleged heart complications, including heart attack, or cardiac event, after dialysis with GranuFlo or NaturaLyte.
What are GranuFlo and NaturaLyte?
A person who has end stage kidney failure, requires dialysis to remove blood toxins and waste products. Fresenius Medical Care owns the majority of dialysis centers in which their products, including GranuFlo and NaturaLyte have been used. Today there are more than 5,500 dialysis centers throughout the United States with over 400,000 dialysis patients undergoing treatment.
Symptoms of GranuFlo and NaturaLyte injuries
GranuFlo and NaturaLyte have been linked to increased levels of bicarbonate in the blood of patients who have used the products during their dialysis treatment. High levels of bicarbonate put patients at six times higher risk for cardiovascular events such as: