Every week, about 400,000 Americans undergo dialysis treatments, sometimes more than once, for their kidney-related complications. Many of these treatments use GranuFlo, which is made by Fresenius Medical Care, the biggest dialysis center operator in the US and the number one supplier of disposal products and dialysis machines used in other clinics. Unfortunately, there have been hundreds of reports linking GranuFlo with serious risks of heart attack, stroke, low blood pressure, metabolic alkalosis, and death.
In Massachusetts, please contact our Boston GranuFlo dialysis injury lawyers at Altman & Altman LLP and request your free case evaluation. Our Boston drug injury law firm represents patients with product defects cases and medical malpractice claims.
It was last year that the US Food and Drug Administration announced the recall of GranuFlo and Naturalyte, another Fresenius dialysis product that has been linked to the same serious health risks. GranuFlo is an acid concentrate powder while Naturalyte is a liquid. The two medications have an ingredient that the body can turn into bicarbonate. While other dialysis meds also have this ingredient, these Fresenium products have more, which may be a reason their patients are more at risk of developing alkalosis, which is a condition linked to a greater risk of cardiovascular conditions. The recall, a Class 1, is the most serious level of recall that the government only puts out when it believes that the risk of serious side effects or death is high.
Meantime, there have been reports that Fresenium knew about the cardiac risks but may have failed to publicly warn about them. An internal company memo notes that there were 900 cardiac deaths linked to Naturalyte and Granuflo in 2010 alone. Yet despite this notation, Fresenium reportedly failed to warn dialysis clinics about the risks involved-especially if either product was not properly prescribed.
Even after the drug maker did put out a wider warning, there have been allegations that the information provided to customers and clinics lacked clarity, specifics, or urgency. The FDA said it would investigate whether Fresenium violated federal laws.
Dialysis serves as an artificial replacement for kidneys, which are supposed to take waste out of the bloodstream. During this procedure, a way to get rid of this waste with bicarbonate, an alkaline substance that is supposed to neutralize the acid that can accumulate in the patient’s blood stream. An overdose of bicarbonate from dialysis treatment may up the risk of death and cardiac arrest , which is why it is important that doctors prescribe the proper dose while accounting for the extra amount found in Granuflo and Naturalyte.
Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry, The New York TImes, June 14, 2012
Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, FDA, March 29, 2012
Dialysis, MedLine Plus
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