FDA Issues Recall of GranuFlo and Naturalyte

On June 27, 2012 the FDA issued a Class 1 Recall of two concentrates used in dialysis, GranuFlo and NaturaLyte, which are manufactured by Fresenius Medical Care. The Class 1 recall is the most serious category of recall, issued when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. “

Company may have delayed warning the public of products’ risks

On March 29, 2012 (a month before the recall), Fresenius had issued a warning about possible adverse side effects from using GranuFlo and NaturaLyte to the public. The warning noted that both products contain acetate, which when combined with a patient’s regular prescriptions, could lead to a bicarbonate overdose, and advised physicians to “exercise their best clinical judgment” in prescribing these concentrates.

However, according to an article in The New York Times, Fresenius had issued an internal company memo about the potential for dosing errors leading to overdose in November 2011 – four months before notifying the public about the risk. The article states that the FDA has launched an investigation into Fresenius due to concerns that the company failed to warn the public about the risks of GranuFlo and Naturalyte in a timely manner.

Dosing errors can cause heart problems and death

On May 25, 2012, three weeks before the Granuflo and Naturalyte recall announcement, the FDA issued a warning to physicians about the risk of dosing errors during dialysis. Dialysis is used to help filter the blood of patients whose kidneys are not functioning properly. During dialysis, concentrated acetic acid and acetate in liquid or powder form are administered to reduce the buildup of acid in the patient’s blood. GranuFlo and Naturalyte are among these concentrates.

The FDA warning alerted doctors to the fact that these concentrates can be converted in the body to bicarbonate, which could cause a bicarbonate overdose and result in a condition called metabolic alkalosis, or pH imbalance in the body. The condition can cause heart problems such as arrhythmia and low blood pressure, increased risk of heart attack, and even death. In fact, more than 900 cases of cardiac arrest were reported in dialysis patients at the Fresenius centers during a single year.

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