Naturalyte, along with Granuflo Dry Acid Concentrate, is used in the treatment of acute and chronic renal failure during hemodialysis. It was specifically formulated to be used with a three-stream hemodialysis machine, which assists in the removal of toxins from the blood when the kidney is unable to do so on its own. Of significant concern, however, are studies that suggest that Naturalyte may be responsible for the overproduction of bicarbonate. Excessively high concentrations of bicarbonate may result in the development of Metabolic alkalosis, a rare but deadly condition.
If you or a loved one has been injured by Naturalyte, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Naturalyte Lawsuit Overview
Fresenius Medical Care, creator of Naturalyte, developed the concentrate for the treatment of acute and chronic renal failure during hemodialysis. Subsequently, it was formulated for the use in a three-stream hemodialysis machine, which is responsible for the removal of toxins from the blood when the kidney is unable to do so.
During hemodialysis patients attempt to remove creatinine, potassium, urea and free water that the kidneys can no longer process. Since the use of hemodialysis attempt to use ultrafiltration across the semipermeable membrane, it has to replace some key components back into the blood. One compound that must be re-introduced is a sodium bicarbonate, which helps to correct blood acidity from the process. However, many medical professionals may be unaware that Naturalyte conversions replace lost sodium bicarbonate on their own. If too much is replaced, serious side effects may ensue.
The increased ratio of bicarbonate created by Naturalyte conversion may coincide with the development of metabolic alkalosis, a severe disorder that can lead to dangerously low blood pressure, cardiopulmonary arrest, severe injury, and death. Do to the rate and severity in which these complications occur, Fresenius Medical Care may become the target of a large Naturalyte lawsuit.
Naturalyte Side Effects
Naturalyte lawsuits are currently evaluating the potential link between the use of this dry acid and the development of the following side effects:
- Cardiopulmonary arrest
- Heart attack
- Low blood pressure
- Metabolic alkalosis
- Hypokalemia (low potassium)
- Hypoxemia (low oxygen in blood)
- Hypercapnia (high carbon dioxide in blood)
- Cardiac arrhythmia
Manufacturer Neglects To Warn Consumers
Officials at the U.S. Food and Drug Administration (FDA) are currently conducting an investigation into whether or not Fresenius Medical Care failed to adequately warn patients about the risk of life-threatening side effects associated with Naturalyte. Complicating the already volatile situation is an internal memo that was distributed to their own dialysis centers in November 2011. However, medical professionals outside of the company received no such memo.
Subsequently, the memo warned of improper administration that may be contributing to a sharp increase in adverse health events, including patient deaths. The memo identified 941 patients who had suffered cardiac arrest in Fresenius dialysis clinics since 2010. By the company’s own estimate, staff concluded that patients with high bicarbonate had a six-fold increased risk of cardiac arrest compared to those with low bicarbonate levels. However, Fresenius neglected to reveal their findings to the FDA or other dialysis centers.
The manufacturer, in association with the U.S. Food and Drug Administration (FDA), issued a warning to clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte 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.
Do I Have a Naturalyte Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Naturalyte lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Naturalyte, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.