GranuFlo and Naturalyte are two drugs used in kidney dialysis, the process of cleaning and filtering the blood for people with severe kidney damage or disease. These drugs are the same compounds, but in different forms. GranuFlo is a powder and NaturaLyte a liquid. The purpose of the drugs in dialysis is to neutralize excess acid in patients’ blood.
The German company Fresenius makes both of these drugs, as well as other medications and equipment used in dialysis. The company provides dialysis for more patients than any other and its products are also used in non-Fresenius dialysis centers. The company came under fire for GranuFlo and Naturalyte when it was discovered that they could cause patients to go into cardiac arrest and die suddenly. Fresenius has been accused of knowing about this risk and not adequately communicating it to patients.
Your kidneys are responsible for filtering impurities from the blood and excreting them from the body in urine. Kidney function is essential and no one can live long without at least one working kidney. When the kidneys start to fail, a person is said to have kidney disease. As function gets lower and lower, a patient will enter end-stage kidney disease and may require dialysis to filter the blood. A patient typically begins dialysis when the functioning of the kidneys is down to 10 to 15 percent of normal function.
End-stage kidney disease can be caused by a number of things, but most often is the result of years of having diabetes or high blood pressure. Other possible causes include autoimmune diseases like lupus, urinary tract problems, genetic disorders, and inflammation in the kidney. All of these causes lead to a chronic form of kidney disease. It may take ten to 20 years before someone with kidney disease reaches the end stages and requires dialysis.
There are two types of dialysis: hemodialysis and peritoneal dialysis. Peritoneal dialysis is less invasive and uses the patient’s own stomach to filter out impurities. Most people with end-stage kidney disease need hemodialysis, a process in which blood is removed from the body, filtered with an artificial kidney, essentially a specialized filter, and then returned to the body. This is done a few times a week for a person in end-stage kidney failure. Without a functioning kidney, this filtration is necessary to keep blood pressure normal and to maintain the proper balance of chemicals in the body.
Fresenius, GranuFlo, and Naturalyte
Most people receive dialysis at a special medical center set up just for that purpose, although some people may be able to do it at home. The largest operator of dialysis centers in the U.S. is Fresenius Medical Care. Around 400,000 people receive dialysis treatment in the U.S., and more than one third of them get that treatment at a Fresenius center. Even in non-Fresenius dialysis locations, much of the equipment and medicine is from Fresenius.
GranuFlo and NaturaLyte, both made by Fresenius, are used in hemodialysis to help filter the blood and to neutralize acid. The active ingredient, sodium diacetate, is converted to bicarbonate in the liver. These products also contain bicarbonate in addition to the sodium diacetate. Bicarbonate is what helps to neutralize extra acid, which would normally be filtered out by a healthy, functioning kidney.
Because GranuFlo and NaturaLyte contain both bicarbonate and sodium diacetate, which gets converted to bicarbonate, patients receiving these products get a double dose of bicarbonate. It helps to neutralize acid, but too much of this compound can cause serious complications, including sudden heart attack and death.
Fresenius Knew the Risks
Lawsuits have arisen against Fresenius, started by people who lost loved ones to sudden death while receiving dialysis with GranuFlo or NaturaLyte. They claim that Fresenius knew about the risks, but did not clearly communicate them to patients or dialysis centers using their equipment and products. The problem with sudden deaths arose because GranuFlo and NaturaLyte contain the extra bicarbonate, but other similar products do not. Not all doctors using these two products realized that there was extra bicarbonate to account for, and patients died as a result.
In 2011 Fresenius sent an internal memo as a warning to doctors, but only to those working in their own dialysis centers. They failed to warn doctors in other dialysis centers using the Fresenius products GranuFlo and NaturaLyte. It was only several months later, after someone anonymously sent the memo to the U.S. Food and Drug Administration (FDA) that Fresenius warned other dialysis centers.
Fresenius has claimed that the only way to communicate the risk to other medical centers was to publish the information in a journal. They claimed to not have enough information or data to warrant a journal article at the time they warned their own clinics. Others disagree and believe that Fresenius could have done more to warn patients and doctors of the risks. Just after Fresenius issued a wider warning, the FDA issued its own warning and a recall of GranuFlo and NaturaLyte.
Once all the information came to light and the FDA got involved, people who lost loved ones to dialysis with GranuFlo and NaturaLyte began filing lawsuits against Fresenius. The claims included that Fresenius knowingly sold dangerous drugs and faulty products and that they failed to warn patients and doctors of the risk of death by heart attack from too much bicarbonate. Deaths that occurred with patients on dialysis with Fresenius’s products have been found to be related to low blood pressure, irregular heartbeats, low potassium levels, and even strokes, in addition to heart attacks.
In addition to individual suits, the state of Louisiana sued Fresenius over GranuFlo and NaturaLyte, requesting $5,000 per violation under the state’s Unfair Trade Practices and Consumer Protection Law and for profits earned on the sale of their products in the state. There have also been a number of class action lawsuits against Fresenius, which most recently resulted in a $250 million settlement. If you lost a loved one to sudden death after receiving dialysis with Fresenius products, you may have a case and a chance to file a suit against Fresenius for monetary damages.