GranuFlo and NaturaLyte, Dialysis Products
Ft. Lauderdale GranuFlo and Naturalyte Attorneys
GranuFlo® (dry concentrate) and NaturaLyte® (liquid concentrate) are components of a widely used dialysis solution manufactured by Fresenius Medical Care (FMC). When added to sodium bicarbonate and purified water the solution is used to clean the blood of hemodialysis patients for treatment of renal (kidney) failure.
FMC discovered their solution made from GranuFlo and Naturalyte were harmful in 2011 but withheld this information from patients and physicians with tragic effects. On March 29, 2012 the Federal Drug Administration issued a Class 1 recall for both drugs, a classification reserved for the most potentially dangerous substances.
What Makes These Dangerous?
Using GranuFlo and Naturalyte can elevate sodium bicarbonate concentrations in the body to dangerous or even deadly levels. While other products contain acetic acid, GranuFlo and NaturaLyte contain the additional component of sodium acetate which is converted to bicarbonate in body tissue during the dialysis treatment. This creates and excess of bicarbonate in the patient which can have catastrophic side effects.
Side Effects from GranuFlo and Naturalyte Include:
- low blood pressure
- heart attack
- heart problems
- cardiopulmonary arrest
- metabolic alkalosis
How FMC Misled the Public
FMC not only manufactures GranuFlo and Naturalyte, but also manufactures a majority of dialysis machinery being used in the United States. In addition, FMC operates over 3,000 dialysis clinics across the country serving over 250,000 patients annually.
According to a leaked, internal memo, FMC was aware of the potential bicarbonate overdose their dialysis drugs caused but failed to warn patients and physicians operating outside of their own dialysis clinics until 2012. It was then that the FDA reviewed the reports and issued a Class 1 recall- reserved for only the most dangerous or deadly products and drugs. The result has placed more than half of all dialysis patients in the United Sates at risk of death.
If you or a loved one has suffered health problems resulting from the use of GranuFlo or NaturaLyte during dialysis treatments, contact an experienced injury attorney at Wolf &Pravato right away. We can review your case and fight to get you what you deserve. Call: Toll-Free (800) 428-3476