Fresenius GranuFlo Product Associated with Severe Heart Problems
GranuFlo has been used by approximately one third of the 400,000 patients with late-stage kidney failure in the United States. This dialysis product from Fresenius is one of the most commonly used drugs of its kind, and evidence shows that the company behind GranuFlo apparently knew that their product caused an increased risk of metabolic alkalosis, with the potential for cardiopulmonary arrest, sudden heart attack, severe stroke and even death.
On November 4, 2011, Fresenius issued an internal memo to its physicians about potential safety problems with GranuFlo. The memo was only sent to the physicians at the company’s own clinics, and not to the approximately 1,800 physicians who used GranuFlo at non-Fresenius clinics.
Fresenius first became interested in the subject of safety back in 2009, after a Boston conference of nephrologists highlighted the problem of cardiopulmonary arrest, and how it was the leading cause of death for dialysis patients. In response to the revelation, Fresenius did a case-control study and located 941 patients who suffered cardiopulmonary arrest during their dialysis treatment at one of the Fresenius clinics in the year 2010. The study confirmed that GranuFlo was a factor with those 941 patient events.
It wasn’t until March of 2012 that the Food and Drug Administration got involved and began investigating the GranuFlo problem. GranuFlo was faced with a Class I recall, the most serious kind of recall. According to the FDA:
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. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
Since the recall, numerous lawsuits have been filed against Fresenius, for failing to warn the public about the dangers associated with its dialysis product. More than that, Fresenius seemingly went so far as to cover up the evidence of heart attack risk, and in doing so placed countless lives in danger.
If you or someone you love has suffered heart attack, cardiopulmonary arrest or stroke after receiving a GranuFlo treatment, contact the GranuFlo lawyers at the Law Offices of Nadrich & Cohen for a free and confidential consultation. We have been monitoring the issue very closely, and we are working with clients in California and throughout the nation to get justice. Call us today at 1-800-718-4658.