Federal regulators are issuing a Class I recall for Fresenius Medical Care’s NaturaLyte and GranuFlo dialysis products. As we’ve reported previously, dosage errors involving GranuFlo and NaturaLyte have been implicated in more than 900 cases of cardiac arrest at Fresenius-owned dialysis clinics.
A Class I recall is the U.S. Food & Drug Administration’s (FDA) most serious category, and is issued for products that pose a risk of serious injury or death.
According to the FDA’s recall notice, the inappropriate prescription of GranuFlo or NaturaLyte 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. These conditions can potentially lead to cardiopulmonary arrest. According to the FDA, GranuFlo or NaturaLyte may cause serious adverse health consequences, including death.
Both GranuFlo and NaturaLyte are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body. Cardiac arrest can occur if a doctor does not account for the higher bicarbonate contribution from GranuFlo or NaturaLyte when deciding how much bicarbonate to prescribe separately.
Earlier this month, The New York Times reported that the FDA is now investigating Fresenius to determine if it violated federal regulations by failing to inform its customer clinics about the risk of heart attack and sudden death associated with GranuFlo and NaturaLyte. According to the Times, Fresenius had issued a memo to its own clinics late last year warning them of the potential risks associated with the two products. According to the November 4 memo, 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. An analysis the company conducted indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients.
While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the public or the FDA about the findings until the agency received an anonymous copy of the memo and inquired about it. Fresenius only issued a warning to its customer clinics this past March, after the FDA began asking questions.