Class I Recall GranuFlo and NaturaLyte–Cardiac Arrests During/After Dialysis Treatment
Posted on November 8th, 2012 by Zane Cagle
As if going through dialysis is not difficult enough, throw in the complication of a cardiac arrest or “cardio event” following dialysis treatment involving GranuFlo and NaturaLyte? How and why is this happening? And, what is a “cardiac event”?
In March of 2012, the Food and Drug Administration (FDA) issued a recall on Fresenius Medical Care North America, NaturaLyte and GranuFlo Acid concentrate. The FDA began investigation of the nation’s largest operator of dialysis centers, Fresenius, to determine if they were failing to notify customers of potentially lethal risk associated with one of their products, Granuflo. Apparently, the FDA investigation began after a reported 900 patients suffered cardiac arrest at Fresenius Dialysis Clinics in 2010.
So what is a “cardiac event” and how do you know if it is not just indigestion? Dr. Garry Mackenzie from McKay-Dee Hospital said that symptoms of a cardiac event can vary from person to person but for the majority of people, the pain is in the center of the chest, behind the sternum. They feel heaviness, pressure and aching and usually make a “clenched fist” when describing the pain. Whereas, someone with heartburn, indigestion usually points to a certain area of the chest. As well, cardiac event victims usually are short of breath and have pain radiating outward, spreading to their arms, shoulders, neck and even the jaw.
While symptoms for indigestion and cardiac events are often similar, doctors warn about self-diagnosis. Left untreated, a real cardiac event can develop into serious heart damage or death. When considering whether or not you or a loved one is having a “cardiac event”, you should examine the symptoms and the person’s medical history. Patients that were treated for dialysis and that were prescribed GranuFlo and NaturaLyte products may not have had any history of heart problems.
Everyone seems to know someone who has gone to the hospital for what they thought was a heart attack and were sent home for indigestion—-it’s embarrassing as no one wants to feel like the pain was “in their head”. Doctors advise patients to seek medical assistance first rather than trying to self-diagnose or wait it out. If dialysis has been completed in the day or days prior to the cardiac symptoms, it is crucial for that person to seek medical attention. ………………………………………..Due to the high numbers of dialysis patients who have suffered various kinds of cardiac events after dialysis even when they did not have a problem in their cardiac history, doctors strongly warn patients to seek immediate help.
According to reports, Fresenius issued an internal memo to all Fresenius clinics on November 4, 2011, warning that 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. The memo sent to doctors practicing in the company’s dialysis centers warned them that failure to properly use one of the company’s products appeared to be contributing to the sharp increase in the risk of patients dying suddenly from cardiac arrest. RenalWEB is a site devoted to dialysis and estimated that 125,000 patients in non-Fresenius clinics are treated with Granuflo. The data reported that excess bicarbonate, or alkalosis, increased significantly the risk of heart problems in hemodialysis patents.
Dialysis takes the place of the kidneys in cleaning toxic waste from the body. Part of this process involves providing bicarbonate, an alkaline substance, to neutralize acid that builds up in the blood. GranuFlo performs different functions, and it contains ingredient providing bicarbonate, and it apparently, it contains more of this ingredient than rival products. Apparently, many doctors have not been accounting for this extra bicarbonate contribution from GranuFlo when prescribing the bicarbonate. The result can be overdose of bicarbonate and some recent studies have suggested that it can lead to a heart problem or “cardio event” such as cardiac arrest.
According to a press release on PR Web, Fresenius Medical Care Warning for Granuflo, NaturaLyte Dialysis Products are a Class I Recall which is the most serious class of recalls. According to the Times, Fresenius is being investigated for failing to warn customers about the risks associated with Granuflo and NaturalLyte.
It would appear that Fresenius alerted their own clinics but not the general public or other clinics using the GranuFlo or NaturaLyte product. It has been questioned whether or not Fresenius action or inaction makes them qualified to advise those clinics using the product.
So what of the hundreds of patients who have suffered a cardiac event following dialysis? Or what of family members who have lost a loved one immediately after dialysis? Commonly, many may think, initially, that the dialysis victim was just in poor health and the cardiac arrest was next. But studies based on actual data and the number of cardiac arrests associated with Fresenius clinics and the use of GranuFlo and NatruaLyte in other clinics indicate that there is a problem with the dosage instructions. At The Cagle Law Firm, we believe it is critical to hold manufacturers accountable for the products that they produce.