From 2010 to Early 2012, Dialysis Patients Were Put at Heart Attack Risk

Kidney patients who underwent dialysis from 2010 to early 2012 were unknowingly put at risk of heart attack because of two dialysis medications, NaturaLyte and GranuFlu, which were ultimately recalled by the FDA. In fact, in 2010, more than 900 patients died of a heart attack after using GranuFlo or NaturaLyte.

What is dialysis?

The kidneys clear toxins and waste from the blood. When kidneys stop functioning properly, salt, toxins, and waste can build up in the blood, which can damage other parts of the body as well as causing symptoms like high blood pressure, rapid heart rate, fluid retention, fatigue, dizziness, decreased immune response, sleep problems, and muscle cramps.

If kidneys lose 85% to 90% of their function, they can no longer adequately clear waste from the person’s system. At that point, the patient requires dialysis, a medical treatment to clear waste, toxins, excessive salt, and extra water from the body.

There are two different types of dialysis: peritoneal dialysis and hemodialysis. Peritoneal dialysis is done inside the body, using the peritoneal membrane in the abdomen to clean the blood of waste and toxins.

In contrast, hemodialysis cleans the blood outside the body by use of a machine called a hemodialyzer (artificial kidney). A tube is inserted into the patient’s veins, and the blood flows outside the body into the machine, where it is cleaned, and then flows back into the patient’s body. To avoid acid buildup during this process, medications like GranuFlo and NaturaLyte are used.

GranuFlo heart attack

GranuFlo and NaturaLyte were both manufactured by a company called Fresenius Medical Care, which is the largest operator of dialysis centers in the U.S. Fresenius also provides dialysis equipment and medications to many other medical clinics, nursing homes, and on-site dialysis providers.

On November 4, 2011, Fresenius sent an internal memo to its own dialysis centers warning doctors that GranuFlo and NaturaLyte had the potential to raise bicarbonate levels in patients’ blood more than other dialysis concentrates. Because doctors were not aware of this risk, they had not been properly adjusting the dosages of GranuFlo and NaturaLyte when using them in dialysis, which could cause the patient to suffer a bicarbonate overdose and result in metabolic alkalosis, a pH imbalance that can cause cardiac problems including arrhythmias and heart attack.

In fact, the memo stated, 941 patients who had died of heart attack at Fresenius dialysis centers in 2010 were found to have high levels of bicarbonate in their blood, indicating that GranuFlo or NaturaLyte may have contributed to their heart attacks.

However, Fresenius did not send the warning memo to doctors outside its own dialysis centers, which meant that patients receiving dialysis using GranuFlo or NaturaLyte in other locations were put at risk of heart attack for several months, since their doctors were unaware of the dosing risk. It was not until the FDA investigated in March 2012 that Fresenius finally warned outside doctors of the risk. Therefore, patients who received dialysis before March 2012 and suffered side effects from using GranuFlo may be eligible for a lawsuit.

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