GranuFlo® and Naturalyte® associated with Cardiac Arrest and Sudden Cardiac Death
New scientific evidence shows that GranuFlo® and Naturalyte®, are associated with with a four- to six-fold increased risk of cardiac arrest and other serious heart problems. Evidence has also shown that officials at Fresenius Medical Care, the company that makes GranuFlo and Naturalyte, knew of this danger but for many months failed to inform its customers, informing only doctors working at FMC-owned clinics.
It is estimated that about 125,000 dialysis patients in the United States are treated with FMC’s GranuFlo® or Naturalyte®.
Fresenius Medical Care (FMC) is the world’s leading provider of dialysis products, treating more than one third of the 400,000 dialysis patients in the United States. FMC not only designs and manufactures dialysis products, but also staffs approximately 1,800 company-owned dialysis clinics across the country.
GranuFlo and Naturalyte Side-Effects Can Be Fatal
An internal memorandum circulated only to all FMC-owned dialysis clinics stated that in 2010, 941 in-center dialysis deaths could be attributed to cardiopulmonary arrest from the use of GranuFlo or Naturalyte. These dialysis products are used to fulfill the normal role of the kidneys, filtering the blood and maintaining a healthy acid-base concentration level in the blood.
Similar products contain ultrapure water, bicarbonate (an alkaline substance), and acetic acid to clean the blood, but instead of acetic acid, GranuFlo and Naturalyte contain sodium Diacetate (acetic acid plus acetate). Due to the fact that when acetate circulates through the body and passes through the liver, it is converted to bicarbonate, an alkaline substance, the overall balance of acid and base in the blood is thrown off, and the blood becomes excessively alkaline. The condition of having excessively-alkaline blood is called metabolic alkalosis, a condition linked with serious health risks such as arrhythmia, cardiac arrest, and even death.
FDA Recall of GranuFlo and Naturalyte
On May 29th, 2012, the United States Food and Drug Administration issued a Class 1 recall of Fresenius Medical Care’s GranuFlo® and Naturalyte® dialysis products. Included in the FDA’s “Reason for Recall,” the FDA comments,
“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 health consequences, including death.”
Have you or a loved one been injured by GranuFlo or Naturalyte?
Anyone who suffered from a stroke, a heart attack, or any other serious heart problem within 48 hours of undergoing dialysis may be eligible to file a GranuFlo lawsuit or a Naturalyte lawsuit. The dialysis lawyers at Dangerous Drugs are interested in speaking with anyone who believes they may be eligible to file a dialysis lawsuit. This includes the loved ones of anyone who may have died as a result of using GranuFlo or Dialysis.
A free consultation is only a phone call or e-mail away. Call 855-452-5529 today or use the contact form on this web site to have a GranuFlo lawyer or a Naturalyte lawyer contact you. Our consultations are free and carry no obligation.