Fresenius Dialysis Problems Result in Granuflo, NaturaLyte Recall

The largest dialysis company in the nation, Fresenius Medical Care, may have failed to adequately warn doctors that its Naturalyte and Granuflo Acid Concentrate products could cause heart attacks and other serious injuries for individuals undergoing hemodialysis. 

The FDA has launched an investigation into the Fresenius dialysis treatment problems after the company failed to promptly issue warnings that the use of Fresenius’ Granuflo and NaturaLyte diaysis drugs may cause metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia. This condition may lead to a heart attack or death for dialysis patients if not appropriately treated.

Fresenius Medical Care runs the largest chain of dialysis treatment centers in the United States, and also supplies other centers with drugs and equipment, including Naturalyte and Granuflo Dry Acid Concentrate, which are used during treatment with a three-stream hemodialysis machine. The company discovered that inappropirate prescription of the dialysis drugs may result in a high serum bicarbonate level, which could contribute to metabolic alkalosis, but appears to have waited months to issue formal warnings.

According to a recent report by the New York Times, the FDA launched an investigation after an anonymous source sent the FDA a memo that Fresenius sent out to doctors working in the company’s own dialysis centers last November, warning about the risk of problems for dialysis patients if doctors improperly used the drugs. However, the information was only provided to doctors working at Fresnius dialysis centers, and the company failed to warn other doctors who treat the estimated 125,000 patients receiving dialysis treatments with the medications at non-Fresenius centers.

In March 2012, Fesenius Medical Care issued a prescribing information notice to these outside customers, warning about the increased risk of cardiac arrest and death, indicating that alkali amounts within the drugs should be factored into the total risk to the patient.

In a notice posted Wednesday, the FDA has classified that action as a Class I recall for NaturaLyte and Granuflo, which is the most serious type of recall, suggesting that continued use of the concentrates in treatment of acute and chronic renal failure during hemodialysis poses a substantial risk of serious injury or death.

The FDA previously issued a safety communication about the risk of problems in May, urging dialysis center workers to be aware of possible dosing errors.

The recall affects NaturaLyte Liquid Acid Concentrate and NaturaLyte Granuflo (Powdered) Acid Concentrate with certain serial numbers, manufactured and distributed from January 2008 through June 2012.

Dialysis is a medical procedure that helps to clean the blood of wastes for patients suffering from kidney failure. The drugs used in the procedure contain acetic acid and acetate, which can increase the risk of cardiac arrest, low blood pressure, heart rhythm problems and chemical imbalances.

Acetic acid and acetates are sources of alkali that, when metabolized, can raise bicarbonate levels in patients going through hemodialysis. This can lead to a condition known as metabolic alkatosis, which can increase the risk of death. The FDA warned that health care professionals may not be aware that the drugs they are using contain the alkali producers.

The FDA investigation looks to see if Fresenius had legal obligations that it failed to meet with the delayed notification. But officials with the company have suggested that they had no system in place to notify everyone it supplied the drugs to outside of the company’s clinics and said that the findings in the November memo were too preliminary to be shared publicly.