FDA Recalls NaturaLyte & GranuFlo due to Cardiac Deaths

There has been a recent recall of NaturaLyte and GranuFlo Acid Concentrate, due to the drugs’ life-threatening risks and the U.S. Food and Drug Administrations’ (FDA) investigation of Fresenius Medical Care.  A number of patients have filed a Fresenius Medical Care lawsuit, and many more are sure to follow as the investigation progresses.

Fresenius Medical Care, based in Germany, is the largest operator of dialysis centers in the U.S., treating as many as one third of the country’s 400,000 dialysis patients. Fresenius is also the leading supplier of dialysis machines and dialysis products in the U.S. and is the manufacturer of dialysis medications, NaturaLyte and GranuFlo. Fresenius provides its dialysis machines and medications to many medical clinics, nursing homes, as well as to its own dialysis centers nationwide.

These medications are used in the treatment of acute and chronic renal failure during hemodialysis. These concentrations help reduce acid build-up in the blood during dialysis. NaturaLyte is the liquid form of the concentration and GranuFlo is the powder form.

On November 4, 2011, Fresenius sent an internal memo to doctors in its co-owned network of dialysis centers, warning of serious risks and side effects found in the use of GranuFlo and NaturaLyte.  In the memo it stated that GranuFlo and NaturaLyte have the potential to raise bicarbonate levels in patients’ blood more so than other dialysis concentrates. Since doctors outside of Fresenius clinics were not made aware of this risk, they were not adjusting the dosages of these concentrates properly, raising the risk of bicarbonate overdose, which could lead to “metabolic alkalosis,” a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, and other conditions, including arrhythmias and heart attack. The memo called the findings “troubling” and warned that “this issue needs to be addressed urgently.”

The memo, which was anonymously leaked to the FDA in March, warned only the doctors working in Fresenius dialysis centers that 941 patients suffered cardiac arrest in 2010 from GranuFlo use. The dangerously high bicarbonate levels put their patients at the risk of cardiac arrest six times higher than that of patients using competitors’ products. All 941 patients had elevated levels of bicarbonate in their blood, indicating that these patients suffered heart attacks resulting from GranuFlo use.

Even though Fresenius Medical Care knew about the alkali dosing errors, they did not issue a warning to the rest of their customers, including nursing homes, medical centers, and on-site dialysis providers, until March 25, 2012 when the FDA put pressure on them. This was four months after Fresenius warned their own doctors in their own clinics.

On June 27, 2012 the FDA issued a Class 1 GranuFlo and NaturaLyte recall.  Class 1 is FDA’s most urgent recall and is used for products that have been found to be extremely dangerous and that “may cause serious adverse health consequences, including death.” A Class 1 recall does not require the removal of the recalled products from the market, but is a serious alert to physicians and clinicians.

On June 28, 2012, Fresenius Medical Care North America announced that it will place updated labels on its NaturaLyte and GranuFlo Acid Concentrate products, and will update their hemodialysis machine operator’s manuals.

RenalWeb is a website devoted to dialysis information. It estimates that 125,000 dialysis patients in non-Fresenius clinics were treated with GranuFlo or NaturaLyte. The patients who were treated with these drugs but were not warned of the potential risks may have grounds for a Fresenius Medical Care lawsuit. However, patients who underwent emergency dialysis treatment, may not know which dialysis drug they were given, and may have experienced adverse side effects, including heart attack or other cardiac issues.

Following the Class 1 recall, many GranuFlo lawsuits have been filed.

Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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