GranuFlo and NaturaLyte are drugs used in kidney dialysis and manufactured by Fresenius Medical Care. A number of people suffered heart problems, some of them fatal, after undergoing dialysis with these drugs. Evidence suggests that Fresenius was aware of these potential dangers, but continued to market and sell the drugs without properly warning consumers and physicians.
Chronic kidney failure affects about 2 out of every 1,000 Americans. Without working kidneys to filter blood, people must undergo hemodialysis – a procedure in which a machine removes toxins and waste from the blood and then returns it to the body. GranuFlo powder concentrate and its liquid counterpart, NaturaLyte, are drugs called a dialysates that are central to the dialysis process. Health-care professionals use them in dialysis machines to neutralize the normal buildup of acid in the blood.
Fresenius Medical Care, the largest dialysis provider in the United States, manufactures both drugs and also ensures their use in its clinics. It also sells the drugs to other dialysis centers.
While GranuFlo and NaturaLyte have the same formula, GranuFlo is unique in that it is a powder acid concentrate. Unlike other acids, the active ingredient in these drugs is sodium diacetate. This dialysate has two parts: acetate and bicarbonate. These two ingredients work together to neutralize excess acid in the blood that accumulates because the kidneys are no longer able to filter it out.
When these two ingredients enter the body during dialysis, the liver converts the acetate into bicarbonate. This means patients who use sodium diacetate receive double the amount of bicarbonate compared to other formulas.
Excess bicarbonate causes a number of complications. The most serious of these is a sudden, fatal heart attack.
An internal company memo surfaces in November, warning medical directors and physicians at Fresenius clinics that GranuFlo was linked to an increased risk of patients suddenly dying from heart attacks, strokes and other fatal complications. The company does not inform physicians outside of its own dialysis centers.
The U.S. Food and Drug Administration (FDA) issues a class I recall for both drugs in May. Class I recalls are the most severe because patients are at risk of suffering complications that may lead to death. The FDA takes issue with these products' potential to increase the amount of serum bicarbonate in the blood to dangerous levels.
Soon after the FDA’s recall, people injured by GranuFlo began filing lawsuits against Fresenius. Some family members filed on behalf of a loved one who suffered a fatal heart attack from the drug. These lawsuits accuse Fresenius of selling a dangerous and faulty product as well as failing to warn doctors and patients.
For all of 2010, Fresenius conducted a study observing patients that had dialysis at its clinics. It found nearly 1,000 people who suffered heart attacks. Researchers noted that GranuFlo and NaturaLyte increased the risk of heart attack by as much as six times. It was then that the company realized that the excess bicarbonate generated by these products was to blame.
Fresenius did not circulate an internal memo to its dialysis centers warning doctors about the problem until nearly a year later – in November 2011. And it did not report its findings to the FDA.
“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the FDA’s medical devices division, told The New York Times.
In March 2013, the FDA received an anonymous copy of the memo and began investigating. The agency then issued the Class I recall and issued a safety communication warning doctors and patients.
Any of bicarbonate-related condition, if left untreated, can also lead to a fatal heart attack. Low potassium levels alone can cause a number of complications.
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People who suffered heart attacks and other complications after receiving GranuFlo and NaturaLyte in dialysis treatment filed lawsuits against Fresenius Medical, and several plaintiffs also filed because their loved ones died of sudden fatal heart attacks linked to these drugs.
The lawsuits claim that Fresenius misled consumers about the products’ safety and continued to profit from the sale of a dangerous drug. Complaints also state that the company intentionally withheld information about the risk of heart attacks from non-Fresenius doctors and healthcare workers.
The state of Louisiana also sued the drugmaker. According to the state’s lawsuit, the company knew that the drugs could cause an increase in bicarbonate levels that may lead to heart attacks, strokes and other complications but chose not to inform the FDA or notify anyone of the risks. Louisiana also accuses Fresenius of defrauding the state Medicaid program.