Critical Study Linking Dialysis Drug, GranuFlo and Cardiac Arrest Withheld
August 10, 2012
At the heart of an ongoing FDA investigation is the timing related to a voluntary recall on two bicarbonate products manufactured by Fresenius Medical Care Holdings, Inc (FMCH) at Fresenius Medical Care North American (Waltham, MA) known to put dialysis patients at an increased risk of a cardiac arrest.
What did the manufacturers know and when, and why did they delay notification to outside dialysis centers?
Naturalyte Liquid Acid Concentrate and GranuFlow Dry Acid Concentrate, both bicarbonate products that dialysis centers around the country rely heavily upon (including locally in Sacramento, California), are suspected in the increased cardiac-related deaths of dialysis patients nationwide.
When improperly administered, a four-to-six fold increased risk of cardiac arrest occurs; a little known fact until recently when internal studies citing the risks were found to be in the manufacturer’s possession.
Plagued by what the FDA referred to as inadequate labeling issues stemming back to 2007 (Naturalyte) and inadequate product training for those who administer the two bicarbonate products, FMCH is alleged to have known that an increased risk of cardiac arrest was associated with the high concentration of their products resulting in abnormally high blood levels of bicarbonate and that they failed to alert outside dialysis centers within a timely manner.
Their alleged inaction is suspected in the cardiac-related deaths of a still unknown number of dialysis patients whose blood levels of bicarbonate became lethal during dialysis.
As a New York Times article explains (June 14, 2012), in addition to manufacturing dialysis machines, disposable products and bicarbonate concentrates, FMCH is also the largest operator of privately owned dialysis centers in the US. Fresenius Medical Care sent an internal memo to doctors throughout the company’s own dialysis centers on November 4, 2011, warning that high blood bicarbonate levels “…appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.”
Specifically, the internal memo cited 941 patients had suffered cardiac arrest within Fresenius’ own facilities in 2010. When compared to other patients, high levels of bicarbonate in the bloodstream resulted in up to six times the risk of cardiac arrest.
Fresenius’s medical office, however, did not issue the same warning to independent dialysis centers throughout the country, which use the products.
It’s been estimated that 125,000 patients are treated with GranuFlo in non-FMCH, independent and community dialysis facilities in the US.
Only after the memo was sent anonymously to the FDA, who in turn began to question the manufacturer, did FMCH issue a voluntary warning (recall) nationwide in March of this year.
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If you or a loved one are a dialysis patient who has suffered a cardiac related event and suspect Naturalyte Liquid or GranuFlo Dry Acid Concentrate was involved, please contact medical device attorneys at Kershaw|Talley immediately for a consultation by calling 888-997-5170, or completing the simple contact form on this page.