GranuFlo and NaturaLyte, both Fresenius Medical dialysis concentrates, have been classified by the U.S. Food and Drug Administration (FDA) as Class I recall products, placing them in the agency’s most serious medical device recall category.
The company, Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis. It also is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.
Fresenius has issued an Urgent Product Notification warning its customers that GranuFlo and NaturaLyte are associated with elevated bicarbonate levels, a significant risk factor for cardiac arrest. According to the FDA, Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.
Dialysis takes the place of the kidneys in clearing toxic waste from the blood. Part of this involves providing bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. GranuFlo and NaturaLyte are alkaline substance administered to dialysis patients to neutralize the acid that builds up in the blood. The products are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body. Many doctors apparently have not been accounting for this extra bicarbonate contribution from GranuFlo when deciding how much bicarbonate to prescribe separately. The result can be, in effect, an overdose of bicarbonate, which some recent studies have suggested could lead to heart problems.
While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the public or the FDA about the findings until the agency received an anonymous copy of the memo and inquired about it.
A number of GranuFlo and NaturaLyte lawsuits had been filed on behalf of victims had been filed before the FDA announced the nationwide Class 1 Recall but the filings significantly increased after the recall was announced. There have been so many such lawsuits filed containing similar life-threatening allegations against the products’ manufacturer, Fresenius Medical Care, that the U.S. Panel on Multidistrict Litigation consolidated a significant proportion of them under the jurisdiction of a single federal judge.
Court records show that there are now 460 cases before Judge Douglas P. Woodlock in the U.S. District for Massachusetts, which represents an increase of 67 cases since the reporting period in November.
The docket of the multidistrict litigation* in the U.S. District Court of Massachusetts summarizes the specific allegations involved:
œThese actions share factual issues arising from allegations that Plaintiffs suffered injury or death caused by the use of GranuFlo and/or NaturaLyte products during hemodialysis, which allegedly may cause metabolic alkalosis in patients resulting in low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.
œAll the actions involve factual questions relating to whether GranuFlo and NaturaLyte were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury and whether it provided adequate instructions and warnings with these products.
Patients suffering GranuFlo side effects from metabolic alkalosis may experience: Hand tremors Confusion Light-headedness Nausea and vomiting Muscle twitching Tetany, or prolonged muscle spasms Tingling or numbness in the hands, feet, or face Warning signs of severe cardiovascular GranuFlo side effects can be noted when a patient begins to experience arrhythmia, or irregular heartbeat. Episodes of apnea may also occur, where the patient stops breathing. During metabolic alkalosis, apneas may occur for 15 or more seconds. GranuFlo side effects can also cause inadequate oxygen intake in the patient. This can lead to cyanosis, or bluish-purplish skin discoloration. GranuFlo side effects from metabolic alkalosis can also include: Hypoxemia, or low levels of blood oxygen Hypokalemia, or low levels of blood potassium Hypercapnia, or high levels of blood carbon dioxide – See more here.
As stated on the FDA website, health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
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