The use of Fresenius Medical Care’s (Fresenius) GranuFlo® and NaturaLyte® in kidney dialysis has been associated with an increase in death, sudden cardiac arrest, cardiopulmonary arrest, heart attack, and other catastrophic cardiovascular injuries.
Fresenius operates kidney dialysis centers across the United States and is the leading supplier of kidney dialysis machines and disposable kidney dialysis products. In addition, Fresenius supplies products used in kidney dialysis to dialysis centers operated by other companies.
What You Need to Know About GranuFlo® and NaturaLyte® The New York Times reports that the U.S. Food and Drug Administration (FDA) is investigating whether Fresenius Medical Care (Fresenius) failed to properly inform some kidney dialysis patients of their risk of cardiac arrest. The concerns involve the use of Fresenius products GranuFlo and NaturaLyte, which have been linked to alkalosis, a condition associated with an increase in death and sudden cardiac arrest in patients undergoing dialysis treatment.
On March 29, 2012, Fresenius issued an "urgent product notification" with "important prescribing information" highlighting the increased risk associated with improper use of GranuFlo and NaturaLyte.
An internal communication from within Fresenius in November 2011 confirmed that the company was aware "patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia."
Additionally, Fresenius indicated that in 2010 alone there were nearly 1,000 patients who suffered from cardiac arrest in dialysis clinics operated by Fresenius, an occurrence they said could be linked to bicarbonate levels in the body. Although the memo warning of the danger of improper use of GranuFlo was sent to clinics operated by Fresenius in November 2011, it is believed Fresenius did not first warn hundreds of non-Fresenius clinics that used GranuFlo and NaturaLyte of the possible problems tied to these products until months later in March 2012.
The FDA is now investigating if non-Fresenius clinic patients were put at a greater risk based on the company’s believed withholding of important safety information.
GranuFlo® in Dialysis Treatment
Dialysis is often used to help patients whose kidneys have failed. During dialysis, the acid in a patient’s blood is neutralized by bicarbonate, an alkaline substance. Products used in dialysis commonly contain ingredients that the body converts to bicarbonate, but the Fresenius product GranuFlo contains a larger amount of this ingredient. It is believed that this large amount can cause an excessive build-up of bicarbonate in the body, which can lead to heart problems—including cardiac arrest (heart attack) or death by sudden cardiac arrest.
Fresenius medical staff determined that the risk of cardiac arrest in patients with high levels of bicarbonate in their blood was six times higher than in patients with normal levels. The FDA issued an alert in May 2012 concerning this risk, and dialysis centers across the country are now checking patients' bicarbonate levels and adjusting their dosages as necessary. If you or someone you love was injured or died from complications related to GranuFlo or NaturaLyte, the kidney dialysis lawyers at our law firm want to help you. Contact us today!
Never stop kidney dialysis treatment without first consulting your doctor. GranuFlo® is a registered trademark of Fresenius Medical Care North America and is used here only for the purpose of identifying the product in question. This law firm is not associated with, sponsored by, or affiliated with the New York Times, the U.S. Food and Drug Administration, or Fresenius Medical Care.