GranuFlo and Naturalyte Side Effects

GranuFlo and Naturalyte are dialysis products that have recently been recalled by the FDA due to the risk of severe, life-threatening injury or death. When the products are administered improperly, a patient may suffer a bicarbonate overdose, which can cause heart attack, stroke, and death. In June 2012, the FDA issued a Class 1 recall of GranuFlo and Naturalyte. Now, the company is facing a growing number of GranuFlo and Naturalyte lawsuits from people who were injured by these products.

Do I Have a GranuFlo or Naturalyte Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by GranuFlo or Naturalyte dialysis treatment, you should contact our lawyers immediately. You may be entitled to compensation by filing a GranuFlo or Naturalyte lawsuit.

What is the problem?

Naturalyte (liquid acid concentrate) and GranuFlo (dry acid concentrate) are two dialysis products that are manufactured by Fresenius Medical Care, a German-based company that owns most of the dialysis clinics in the United States and also manufactures dialysis products.

Naturalyte and GranuFlo are products that balance the acidity and alkalinity of blood before it is delivered to a patient. Most other acid concentrates consist primarily of acetic acid. Naturalyte and GranuFlo contain acetic acid plus another chemical, sodium diacetate, which is converted to bicarbonate by the patient’s liver and tissues.

If a doctor is not very careful with the dosage, the patient can easily suffer a bicarbonate overdose, causing a condition called metabolic alkalosis.

FDA Warnings for GranuFlo, Naturalyte

The FDA has issued a Class 1 recall of the Fresenius GranuFlo and Naturalyte. 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, in November 2011, Fresenius sent a memo to their own doctors warning about the potential for bicarbonate overdose and death. Fresenius noticed 941 deaths at their clinics since 2010, and they found that patients who had a high bicarbonate levels before dialysis were six times more likely to have a heart attack.

Fresenius did not notify the FDA of the issue, nor did they warn doctors at other dialysis clinics that were also using GranuFlo and Naturalyte. The FDA only became aware of the issue when an anonymous source sent the FDA a copy of the memo. When the FDA questioned Fresenius about the memo, the company voluntarily agreed to issue a recall.