Popular Dialysis Drugs GranuFlo and NaturaLyte Cause Serious Injuries & Side Effects

If you have been injured in dialysis treatment, you may be eligible for compensation. For legal consult fill out the form on the right or call 888.584.0411. 

If you have suffered any of the following side effects, the injury may have been caused by dialysis products that were used in many dialysis centers despite risks only the manufacturer knew about.

Side effects include low blood pressure, heart attack, heart problems, cardiopulmonary arrest, metabolic alkalosis, stroke, and death.

Because of serious GranuFlo® and NaturaLyte® side effects, the U.S. Food and Drug Administration (FDA) has announced a Class 1 recall on the dialysis products. The two potentially dangerous pharmaceuticals are acid concentrates diluted to become a component of dialysate, which is used to clean the blood of patients undergoing hemodialysis for treatment of renal (kidney) failure.

Both GranuFlo, as a dry concentrate, and NaturaLyte, as a liquid concentrate are components of the final dialysis solution. The solution is diluted with purified water and combined with sodium bicarbonate—for cleaning a patient’s blood and replicating their kidney function.

How Potential Overdosing Can Occur

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.

This makes correct acid and bicarbonate levels absolutely essential. Incorrectly mixed dialysate that results in increased bicarbonate levels can place patients at an increased risk of metabolic alkalosis —a dangerous GranuFlo side effect.

Note, GranuFlo and NaturaLyte are not inherently dangerous products, but become dangerous pharmaceuticals when errors occur in their mixing and administering.

Company Misled Public

Fresenius Medical Care (FMC) manufactures GranuFlo and NaturaLyte, as well as many of the machines and products used in dialysis treatments. FMC is also one of the largest dialysis clinic operators in the world.. In 2011, FMC issued an internal notice to its company-owned clinics, warning of the risks and side effects of the products; however, they failed to offer warnings to thousands of physicians and clinics not owned by FMC who continued to use their product.

As a result of the memo leaked to the U.S. Food and Drug Administration in 2012, the FDA issued a Class 1 recall of all GranuFlo and NaturaLyte products. If you or a loved one is undergoing dialysis, take these steps immediately:

  1. Protect yourself by reviewing patients at most at risk.
  2. Ensure that your physician is properly formulating yours—or your loved ones—dialysate at your clinic.
  3. Fill out form to the right, so that Seeger Weiss LLP attorneys can assess your individual situation. Make sure to inform us whether you have suffered from cardiac arrest, heart attack, or other illnesses following dialysis.
Seeger Weiss LLP

Seeger Weiss LLP is now accepting new clients who have been harmed by FMC’s intentional efforts to mislead the public about the safety of its products.

Complete the form to the right for free legal evaluation.

Additional cases Seeger Weiss is investigating include:












 

Have you or a loved one been injured from dialysis treatment? You may be entitled to damages. Fill the form below for a free legal consultation.

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