Did Fresenius Act Improperly in Granuflo Recall?

Philadelphia, PAIn March 2012 a Granuflo recall was announced due to a concern about serious adverse health events, including possible death for patients who received Natrualyte or Granuflo as part of their dialysis. The Fresenius Medical Care recall was reportedly only announced, however, after the US Food and Drug Administration (FDA) received a copy of a letter Fresenius sent to certain—but not all—healthcare professionals regarding alkali dosing errors. There are now questions about whether or not Fresenius acted properly when it sent out its warning letters.

The Naturalyte and Granuflo recall was issued after concerns were raised that some patients might be exposed to increased serum bicarbonate levels, which could cause metabolic alkalosis. Metabolic alakosis is, in turn, linked to low blood pressure, hypokalemia, hopyxemia and cardiac arrhythmia. As such, high serum bicarbonate levels can cause serious adverse health consequences, including death.

"Health care professionals may not be aware that the dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis," the FDA warned in its May 25, 2012 safety communication.

Naturalyte and Granuflo Dry Acid Concentrate are used during hemodialysis to treat acute and chronic renal failure. They are used both at Fresenius dialysis centers and medical centers not linked to Fresenius. According to reports, Fresenius issued a warning about the risk of cardiac arrest and other heart problems linked to Naturalyte and Granuflo in November, but that memo went only to Fresenius centers. It was reportedly not sent to outside centers, despite the products being used at outside medical centers.

According to the memo, "borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with 6 to 8 fold greater risk of CP arrest and sudden cardiac death in the dialysis facility" (italics in original). Fresenius went on to recommend that in light of the findings, "physicians adjust dialysate bicarbonate prescriptions monthly for individual patients, with immediate attention to patients with serum pre-dialysis bicarbonate level of >24 mEq/L."

This means that patients at outside medical centers could have been at unnecessary increased risk of elevated serum bicarbonate levels because their physicians would not have received the same information.

Once the FDA received information about Granuflo and Naturalyte, the agency issued a Class 1 recall of certain lots of the products.