DIALYSIS PRODUCTS PUT PATIENTS AT HIGH RISK
OF SUFFERING LIFE-THREATENING HEART PROBLEMS
As more facts become public about the actions of the manufacturer of two of the most popular kidney dialysis products – GranuFlo and NaturaLyte – involving life-threatening side effects, more questions are being raised about the patient safety.
Fresenius Medical Care, which is the preeminent provider of dialysis machines and treatment products, apparently was well aware that these two dialysis products put patients at six times the risk of suffering severe heart problems and other serious health problems but failed to warn many of their customers.
Typically, in the case of such alarming circumstances there are usually follow-up studies by medical researchers, a review by the Food and Drug Administration and a wave of lawsuits by patients who may have suffered these side effects or by plaintiffs who may have lost a loved one because of their use of a medication or medical device.
The New York Times published a revealing and disturbing article citing internal Fresenius documents which show that after company officials became aware of the problem they sent out warnings to doctors at Fresenius-operated clinics but did not do so to non-Fresenius clinics. It’s difficult to determine who many patients may have been left out in the cold about these serious health risks but it is estimated that about one-third of the U.S. patients receiving dialysis are treated with Fresenius products.
The Times asked Steven Silverman, director of compliance for the agency’s medical services division about the situation and he had a negative reaction:
“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern. Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”
The FDA also confirmed to the Times that it has launched an investigation into whether Fresenius may have violated federal laws “by failing to inform customers of a potentially lethal risk connected to one of its products.”
Kidney dialysis is a medical process in which the dialysis essentially assumes the role of the kidneys by clearing toxic waste from the body. It is an essential treatment for kidney victims and GranuFlo and NaturaLyte are two of the most popular products used in conjunction with this process.
However, as the FDA has confirmed and Fresenius finally acknowledged in a joint public health alert, there are severe dangers being reported from the levels of bicarbonate, an alkaline substance utilized to neutralize the build-up of acid in the bloodstream, contained in these products.
Fresenius experts, in their own memos, were finding that their products were causing such high levels of bicarbonate that patients were being put at six times the risk of suffering a stroke or heart attack than patients who were using other products.
To compound the problem, Fresenius officials notified Fresenius-operated dialysis clinics about the problem but did not notify other clinics using their products.
Then, a few days after the Times article, the FDA announced a Class 1 Recall of certain lots of the NaturaLyte and GranuFlo Dry Acid Concentrate used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
The FDA said the recall was initiated by Fresenius Medical Care of North America, which claims to treat over one-third of all of the country’s dialysis patients with its products. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The FDA also said that the manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. Officials said that inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.
What was not included in the press released from the FDA and Fresenius was any mention about the fact FDA officials have confirmed that they are conducting an investigation into whether Fresenius may have violated federal regulations by failing to inform health care professionals and customers at outside clinics about this problem. Also not mentioned were media reports that company officials were aware of dangers from these products and did not inform all patients or clinics that might have been using the products.