Kidney dialysis is a procedure of last resort for patients with kidney failure and those waiting for a donor organ. To filter the blood artificially through dialysis, medications are needed including those that help to neutralize the acidity in the blood. GranuFlo and NaturaLyte are two products that do this and both are made by German company Fresenius.
The use of dialysis comes with risks and side effects, so too do GranuFlo and NaturaLyte. These two products made by Fresenius are used in the majority of dialysis centers in the U.S., but they have been found to cause sudden and unexpected heart attacks in some patients. Some of these people have died as a result and Fresenius has been blamed for not providing all the information doctors and other health care workers needed to properly administer the dialysis drugs.
Kidney Failure and Dialysis
The kidneys are the organs responsible for filtering the blood in the body and passing the waste products into the urine and the bladder for excretion. When the kidneys fail, a person cannot live long and needs either a transplanted kidney from a donor or regular dialysis treatments to artificially filter the blood. Kidney failure is considered to have occurred when they kidneys are only functioning at ten to fifteen percent.
Kidney failure is the end stage of kidney disease, which may be the result of a number of factors. Most commonly someone ends up with kidney failure from years of high blood pressure or diabetes. Genetic conditions, autoimmune disorders, and inflammation can also trigger kidney disease and ultimately lead to failure.
When an organ transplant is not an option for someone with kidney failure, dialysis must be used to keep the person alive. There are two types of dialysis. Hemodialysis is used most commonly for people with end-stage kidney disease. It uses a machine to filter the blood. The blood has to be removed from the body, run through the filter, and put back into the body.
Peritoneal dialysis is less invasive, but not recommended for most people with kidney failure. It involves using the stomach as a filter so that blood does not have to be removed. A patient can do this at home without a health care professional, but hemodialysis must be done at a dialysis center or at home with a dialysis machine and a trained health care worker.
Side Effects of Dialysis
GranuFlo and NaturaLyte are part of hemodialysis, and have been found to cause some serious side effects, but the process of dialysis itself can also lead to side effects. Peritoneal dialysis, for instance, can cause infections at the catheter site. It can also result in a hernia because the catheter inserted into the abdomen tends to weaken muscles. Weight gain and bloating are also characteristic side effects of this type of dialysis.
For hemodialysis it is common for patients to experience infections as well. These patients are also vulnerable to low blood pressure because of the removal of blood. This leads to feelings of dizziness and nausea. Muscle cramps, especially in the legs, and sexual dysfunction are also common with hemodialysis.
GranuFlo and NaturaLyte
To filter the blood during hemodialysis, certain substances must be added to it. GranuFlo and NaturaLyte are two of these. One is a liquid and the other is a powder, but they include the same ingredients and have the same purpose of neutralizing excess acid in the blood. The active ingredient is sodium diacetate. When given to the dialysis patient this is converted in the liver to bicarbonate, which is the compound that neutralizes acidity.
Fresenius is the maker of these two products and the company also makes many other dialysis products and medical devices. The company also runs many dialysis centers, more than any other company in the U.S. Most people needing dialysis will use Fresenius products or go to their centers at some point. Because Fresenius dominates this market, when something went wrong with NaturaLyte and GranuFlo, a lot of people were exposed to the harmful side effects.
A terrible side effect that too many dialysis patients experienced was a sudden and unexpected heart attack. The problem was that GranuFlo and NaturaLyte contained both sodium diacetate and bicarbonate. Medical professionals administering them did not necessarily know that they contained bicarbonate. If they dosed a patient not knowing this, that patient would end up with more bicarbonate in the blood than was needed, with frightening consequences.
Too much bicarbonate in the blood can lead to heart attack and death. Because Fresenius did not make it clear that GranuFlo and NaturaLyte contained both compounds, a lot of patients were essentially overdosed. Fresenius conducted its own study of the side effects of its products and found that in just 2010 the medications caused over 900 heart attacks in dialysis patients.
What Fresenius Knew About Side Effects
Because Fresenius knew that there was a risk of heart attacks in patients being given NaturaLyte and GranuFlo, the company has since been criticized and sued for failing to warn all people who could potentially be affected. Once the company knew about the risk it did send out a memo, but only internally. Any professionals working in non-Fresenius clinics and dialysis centers were not warned about the dosing problems.
An anonymous whistleblower sent the memo to the U.S. Food and Drug Administration and the message finally got out to all people impacted by GranuFlo and NaturaLyte. Fresenius has defended its actions, or inactions, by claiming that it could not communicate the risk outside of its own company unless it published the information in a journal, and that the data were not ready for publication yet.
Many people and even some state governments have sued Fresenius over the GranuFlo and NaturaLyte side effect of heart attacks. People have died and many believe that the company is negligent because it did not take all necessary steps to warn patients and people working in dialysis centers. The company denies any wrongdoing, but has paid out settlements.