FDA Investigates Dialysis Company for Failure to Warn

The Food and Drug Administration (FDA) is investigating Fresenius Medical Care, the country's largest operator of dialysis centers, over allegations that it failed to inform customers of potentially lethal risks associated with one of its products. The FDA's investigation will try to determine if the company's omission violated federal law.

In addition to operating dialysis clinics, Fresenius supplies dialysis machines and disposable products to clinics across the country. Dialysis machines filter patients' blood with dialysate, a product that removes unwanted waste products. Dialysis treatments are given to patients with kidney malfunction or failure, since their renal organs can longer sufficiently clear waste from the blood.

In November 2011, Fresenius' medical office sent an internal memo, obtained by the dialysis website RenalWEB, to doctors in the company's own dialysis centers, warning that failure to properly use a product known as GranuFlo correctly was contributing to a noticeable increase in patients' risk of dying from cardiac arrest. GranuFlo is a dry acid product used in the dialysis process. Compared to other products on the market, GranuFlo contains much more of an ingredient that converts to bicarbonate in the body. Apparently doctors were not aware of the excess quantity of the ingredient in GranuFlo, and were still prescribing additional bicarbonate prescriptions to dialysis patients. The over subscribing could potentially lead to a bicarbonate overdose, which, in turn, could cause heart problems for patients.

According to the memo, 941 patients had suffered cardiac arrests in Fresenius clinics in 2010; company physicians found that, when compared to other patients, those with higher blood bicarbonate levels were at a six-times-greater risk of cardiac arrest than those with lower levels. Despite sharing this critical information with physicians working at their own clinics, Fresenius' management team did not inform their other customers of the risk until March of this year, and then only because the FDA was sent an anonymous copy of the November internal memo. Following the March notification, the FDA issued a safety alert relating to all products that, like GranuFlo, contained ingredients which could be converted to bicarbonate in the body. According to RenalWEB, an estimated 125,000 dialysis patients being treated with GranuFlo at non-Fresenius clinics were put at risk by the company's failure to warn.