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Naturalyte and GranuFlo Side Effects

Naturalyte and GranuFlo Side Effects

Naturalyte and GranuFlo have been linked to severe side effects, including heart attack, stroke, and death. Unfortunately, there is evidence that Fresenius (the company that manufactures Naturalyte and GranuFlo) waited several months to inform the FDA about the risk of side effects. In June 2012, the FDA issued a Class 1 recall of these products. Now, Fresenius is facing a growing number of lawsuits from people who were severely injured by these products.

What You Can Do & How a Naturalyte or GranuFlo Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Naturalyte and GranuFlo induced injury cases in all 50 states. If you or somebody you know has been injured by Naturalyte or GranuFlo dialysis treatments, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Granuflo Lawyer Michael Schmidt Elected to the Granuflo and Naturalyte Plaintiff’s Steering Committee for Injury Claims in All 50 States

Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP and The Schmidt Firm, PLLC, was recently elected to the Plaintiffs’ Steering Committee in the Judicial Council Coordination Proceeding No. 4749 in Los Angeles Superior Court. The coordination proceeding applies to Granuflo and Naturalyte injury claims nationwide.  This appointment establishes Mr. Schmidt in a leadership position in the litigation along with rest of the JCCP leadership panel. 

A nationwide recall was issued for NaturaLyte and GranuFlo on March 29, 2012. Use of Fresenius Medical Care’s popular dialysis treatment products GranuFlo and NaturaLyte has been linked to a six-fold increased risk of cardiopulmonary arrest and sudden cardiac death.

What is the problem?

Naturalyte (liquid concentrate) and GranuFlo (dry concentrate) are dialysis products manufactured by Fresenius Medical Care. Both products are administered during kidney dialysis. They are used to balance the acidity and alkalinity of the blood.

Most acid concentrates for dialysis contain primarily acetic acid. The problem is that Naturalyte and GranuFlo contain acetic acid plus an ingredient that converts to bicarbonate by a patient’s liver and tissues. Unfortunately, if a physician is not very careful with the dosage, the dialysis patient can easily suffer from bicarbonate overdose, which causes a condition called metabolic alkalosis.

FDA GranuFlo, Naturalyte Warning

The FDA has determined that Fresenius Naturalyte and GranuFlo are unsafe because they can potentially cause severe injury or death. According to the FDA:

“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.”

Failure to Warn About Side Effects

According to a New York Times investigation, Fresenius sent a memo to doctors at their own clinics on November 4, 2011, warning about the risk of bicarbonate overdose. The memo was not sent to doctors at other dialysis clinics or the FDA. In fact, the FDA only became aware of the potential safety hazard after an anonymous source sent the memo to the FDA.

The memo warned that Fresenius had noticed a sharp uptick in patient deaths, which they attributed to high pre-dialysis bicarbonate levels. There were 941 deaths at Fresenius clinics since 2010, and by the company’s own analysis, patients with high bicarbonate levels were six times more likely to suffer cardiac arrest during dialysis.

Naturalyte & GranuFlo Side Effects

When GranuFlo and Naturalyte are administered properly, they do not usually cause the following side effects. These side effects are most likely to occur when a physician makes a mistake with the dosage of GranuFlo or Naturalyte — causing a life-threatening bicarbonate overdose.

Severe side effects of GranuFlo and Naturalyte include:

  • Cardiopulmonary arrest
  • Heart attack
  • Cardiac arrest
  • Stroke
  • Low blood pressure
  • Metabolic alkalosis
  • Low potassium in the blood (hypokalemia)
  • Low oxygen in the blood (hypoxemia)
  • High carbon dioxide in the blood (hypercapnia)
  • Sudden irregular heartbeat or rate (arrhythmia)
  • Death

If you or your loved one was injured by Naturalyte or GranuFlo during dialysis treatment, you are not alone. If you decide to file a lawsuit, you could be entitled to significant financial compensation for your pain, suffering, medical expenses, or wrongful death of your family member.

Do I have a Naturalyte or GranuFlo Lawsuit?

The Schmidt Firm, PLLC is currently accepting Naturalyte and GranuFlo induced injury cases in all 50 states. If you or somebody you know has been injured by Naturalyte or GranuFlo dialysis treatments, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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