GranuFlo and NaturaLyte Linked to Heart Attack, Cardiac Arrest

The purpose of the kidneys is to clean waste and water from the blood. If the blood is not cleaned, the toxins can build up and cause harm. A patient with late stage kidney failure must rely on hemodialysis in order to clean the blood.

During hemodialysis, the blood is filtered through an artificial kidney or dialyzer. The dialyzer contains a fluid called a dialysate. The dialysate draws fluids and toxins out of the bloodstream and adds electrolytes and other necessary chemicals to the bloodstream. NaturaLyte Acid concentrate and GranuFlo Dry Acid Concentrate are examples of dialysates.

On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall of the dialysis drugs NaturaLyte and GranuFlo. A Class I recall is issued when the use of a drug is considered likely to cause serious illness or death.

The recall occurred after it was found that GranuFlo and NaturaLyte are linked to heart problems and other medical conditions when used incorrectly.

Most patients undergoing dialysis have acidic blood. They are prescribed bicarbonates during the dialysis process; the bicarbonates neutralize the acids. The increased risk of cardiac arrest occurs because GranuFlo contains an ingredient that is converted into bicarbonate during the dialysis process. When a physician fails to account for the bicarbonate provided through GranuFlo and writes a separate bicarbonate prescription, the patient can end up with too much bicarbonate in the blood. This condition is known as metabolic alkalosis, a condition that is linked to heart problems.

Both NaturaLyte and GranuFlo are manufactured by the German company Fresenius. Fresenius Medical Care North America is the largest operator of dialysis centers in the United States and the nation’s largest supplier of dialysis supplies. About one-third of the 350,000 American who receive dialysis at outpatient centers use a clinic owned by Fresenius. There are ten Fresenius-owned clinics in Memphis.

In November 2011, Fresenius sent an internal memo sent to doctors working in Fresenius-owned dialysis centers warning that the misuse of GranuFlo seemed to contribute to as much as a six-fold increase in the risk of patients dying from cardiac arrest. The company did not report its findings to the FDA, nor warn other doctors using Fresenius products. The FDA is investigating Fresenius to determine if any laws or federal regulations were broken.

If you have experienced cardiac arrest or other serious side effects after dialysis treatment with GranuFlo or NaturaLyte, you have the right to file a Tennessee pharmaceutical injury lawsuit. To learn more, contact a Memphis drug injury lawyer. Contact Bailey & Greer at 901-680-9777 to schedule a free legal consultation.