Fresenius Medical Care, the Nation’s largest operator of dialysis centers, is under investigation by the FDA for failing to warn customers of potentially deadly heart problems associated with the company’s GranuFlo® and NaturaLyte® dialysis products.
Dialysis is a procedure that replaces the function of the kidneys by filtering toxic waste products out of the blood. GranuFlo® and NaturaLyte® are products used in the dialysis process. Bicarbonate is a chemical that dissolves acid in the blood. The issue with GranuFlo® and NaturaLyte® is that they produce more bicarbonate than their competitors, which can lead to excessively high alkaline levels, or metabolic alkalosis. Metabolic alkalosis increases the risk of serious complications, such as:
- Sudden Cardiac Arrest
- Sudden Heart Attack
- Hemodialysis cardiac arrest
- Hemodialysis cardiopulmonary arrest
- Stroke
- Death
- Arrhythmia
- Altered mental status (confusion)
- Low blood pressure
Physicians who were not aware of the extra bicarbonate resulting from GranuFlo® and NaturaLyte® may have prescribed even more bicarbonates, essentially giving patients an overdose. The resulting excessive levels of alkaline can lead to serious heart problems.
According to news reports, Fresenius sent an internal email in November 2011, warning doctors at its own dialysis centers that the use of GranuFlo® and NaturaLyte® contributed to an increased risk of death from cardiac arrest during dialysis. However, a similar warning did not go to the FDA, other doctors, or consumers. A subsequent warning was finally sent in March 2012 after the FDA saw a copy of the memo. Questions have arisen as to whether the company’s conduct put patients at risk and violated FDA regulations and ethical standards.
If you suffered harm that you believe may have been caused by GranuFlo® and NaturaLyte® dialysis products, please contact the dangerous medical device attorneys at Golomb & Honik, P.C. for a no-cost evaluation. We welcome prospective clients from Pennsylvania, New Jersey and nationwide.
