GranuFlo/Naturalyte Fresenius Dialysis
FDA Issues Recall for GranuFlo® and NaturaLyte® Fresenius Dialysis Products Due to Heart Attack and Stroke Risk
Dialysis Cardiac Arrest Heart Attack | Lawsuits, Lawyers | Side Effects: Sudden Heart Attack, Stroke, Death, Arrhythmia, Altered mental status (confusion), Hemodialysis cardiac arrest, Hemodialysis cardiopulmonary arrest, Low blood pressure
Fresenius Medical Care, the largest operator of hemodialysis clinics in the U.S., as well as the leading supplier of dialysis machines and disposable products and supplies, is under investigation for failing to inform customers of a potentially deadly heart risk connected to excessive doses of the company’s GranuFlo and NaturaLyte dialysis products.
Most patients receiving dialysis have the expectation that the products being used during dialysis are safe and, therefore, are generally unaware of the specific names of the products used during their treatment, such as GranuFlo and NaturaLyte. In addition, because many of the facilities use local names it is possible that dialysis patients do not know if they are receiving dialysis at a Fresenius Medical Care affiliated facility. Parker Waichman LLP investigates these issues on behalf of our clients to determine if their injury is related to the products GranuFlo and NaturaLyte or a Fresenius Medical Care affiliated facilitated.
According to the U.S. Food & Drug Administration (FDA) and Fresenius, GranuFlo and NaturaLyte can contribute to elevated bicarbonate levels in patients, leading to hemodialysis metabolic alkalosis, a significant risk factor for a variety of heart and health problems, including:
- Sudden Cardiac Arrest
- Sudden Heart Attack
- Hemodialysis cardiac arrest
- Hemodialysis cardiopulmonary arrest
- Altered mental status (confusion)
- Low blood pressure
Patients who suffered cardiac arrest or heart attack connected to the administration of GranuFlo and NaturaLyte at a Fresenius facility or other dialysis clinic using a dialysis supply distributed by Fresenius Medical Care called GranuFlo and NaturaLyte may be entitled to compensation. The GranuFlo and NaturaLyte dialysis lawyers at Parker Waichman LLP are offering free personal injury lawsuit consultations to victims of dialysis cardiac arrest, as well as their families. If you or someone you love suffered a dialysis cardiac arrest or heart attack that could be connected to GranuFlo and NaturaLyte, it is vital you contact the attorneys at Parker Waichman LLP by calling 1-800- YOURLAWYER (1-800-968-7529) today.
Fresenius GranuFlo and NaturaLyte Dialysis Heart Attack Warning
Dialysis is a procedure that clears toxic waste from the blood in people whose kidneys have failed. In dialysis, bicarbonate, an alkaline substance, is administered to neutralize the acid that builds up in the blood. Fresenius Medical Care’s GranuFlo and NaturaLyte contain an ingredient that the body converts to bicarbonate at higher levels than rival products. GranuFlo and NaturaLyte are used at Fresenius' own clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius Medical Care. It is estimated that roughly 125,000 patients in non-Fresenius clinics are treated with GranuFlo and NaturaLyte.
On its product website, Fresenius touts GranuFlo and NaturaLyte as the "most-widely prescribed dry acid product in the dialysis industry today." The company further claims that: "With GranuFlo’s distinctive proportional component blend in each bag, you have made the safest choice for onsite concentrate mixing."
However, an internal company memo sent to doctors operating in its own clinics directly contradicts Fresenius' assertions of GranuFlo and NaturaLyte’s safety. The memo, dated November 4, 2011, warned that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. According to the memo, doctors' failure to use GranuFlo and NaturaLyte correctly appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. GranuFlo and NaturaLyte is prescribed in conjunction with bicarbonate, and doctors apparently were not accounting for the higher bicarbonate contribution from GranuFlo and NaturaLyte when deciding how much bicarbonate to prescribe separately. According to the Fresenius memo, the company's medical staff concluded that dialysis patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.
High levels of bicarbonate can lead to serious, even fatal consequences. This risk was highlighted at the 2011 annual meeting of the American Society of Nephrology, where researchers presented data showing increased mortality with high levels of bicarbonate. According to the presentation, a study involving 16,899 patients showed that excess levels of bicarbonate can lead to metabolic alkalosis, a potentially fatal condition. The presenters concluded that the evidence warranted further research.
On March 27, 2012 the FDA inquired about these risks and began investigating Fresenius about the risk of high bicarbonate levels and subsequent alkalosis. This inquiry prompted Fresenius Medical Care to issue a two-page Urgent Product Notification to non-Fresenius clinics. Shortly afterwards, the FDA issued a Class I recall for GranuFlo and NaturaLyte products manufactured between January 2008 and June 2012. A Class I recall is the agency’s most serious recall status; it means that exposure to the product can lead to serious and perhaps life-threatening health issues. What is even more disconcerting is the fact that Fresenius officials knew about the dangers of excess bicarbonate long before the internal memo came to light. The company was aware of the risks of high bicarbonate when the products were approved in 2003, but chose to not warn patients, the FDA or clinics.
In late May 2012, the FDA informed dialysis centers throughout the country that it had received a complaint describing "alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate." According to the agency, when metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with a number of serious side effects, including cardiopulmonary arrest, low blood pressure, cardiac arrhythmia and death.
Legal Help for Victims of Fresenius GranuFlo and NaturaLyteCardiac Arrest
If you or a loved one suffered cardiac arrest while undergoing dialysis, a bicarbonate overdose from Fresenius Medical Care's GranuFlo and NaturaLyte products might be to blame. Victims of GranuFlo and NaturaLyte heart problems may have valuable legal rights. For a free legal evaluation of your case, please contact the lawyers at Parker Waichman LLP today by filling out our online form, or call 1-800-YOURLAWYER (1-800-968-7529).