GranuFlo and NaturaLyte are pharmaceuticals used in dialysis to treat end-stage renal disease, also known as kidney failure. The two pharmaceuticals are acid concentrates diluted with purified water and combined with sodium bicarbonate for cleaning a patient’s blood and replicating their kidney function.
These dangerous drugs are given to more than a third of the nearly 400,000 Americans who receive dialysis treatment each year. Many dialysis patients don’t know they were given GranuFlo or NaturaLyte products and may have suffered severe side effects. The U.S. Food and Drug Administration has issued an emergency recall of GranuFlo and NaturaLyte after increased reports of severe, adverse side effects being reported by dialysis patients, including death.
GranuFlo and NaturaLyte Side Effects
Dialysis patients on GranuFlo and NaturaLyte are up to six times more likely to suffer cardiopulmonary arrest and sudden cardiac death. Those who have undergone dialysis may suffer from:
- Low blood pressure
- Heart attack
- Heart problems
- Cardiopulmonary arrest
- Metabolic alkalosis
FDA Investigation of GranuFlo & NaturaLyte
The FDA’s investigation has revealed that doctors were administering the drug at too high a level for healthy human consumption. GranuFlo and NaturaLyte help kidney failure patients during the process of dialysis by converting into bicarbonate, which helps the bloodstream of a patient in a way that the kidneys would otherwise be able to do. Other acid concentrate products consist primarily of acetic acid, but GranuFlo and NaturaLyte contain acetic acid plus sodium acetate (sodium diacetate). Sodium acetate gets converted into bicarbonate by the patient’s tissues/liver, effectively increasing bicarbonate levels beyond what was initially prescribed. Increased bicarbonate levels can place patients at an increased risk of metabolic alkalosis, a dangerous side effect.
Manufacturer’s Failure to Notify Public
Fresenius Medical Care is a German company with offices in Waltham, Massachusetts operating under the name Fresenius Medical Care North America. FMC is the largest operator of hemodialysis centers in the US. According to FDA findings, Fresenius Medical Care failed to warn patients and doctors about the risks and severe side effects of GranuFlo and NaturaLyte, despite having issued an internal notice to its company-owned clinics warning of the risks and side effects of the products one year earlier. The company intentionally withheld safety information regarding its products and created unreasonable risk to patients undergoing dialysis and utilizing GranuFlo and NaturaLyte.
If you or a loved one were injured during or after kidney dialysis treatment, you may be entitled to significant compensation. Please contact Bernheim and Dolinsky, LLC today at 1-800-474-4089 or online to discuss the particular facts of your potential case. Our experienced pharmaceutical drug attorneys will discuss your potential case and explain what we can do for you.
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