Fresenius Faces Recall Investigation

“Our number one goal is to provide the best quality care possible to help patients live a better life on dialysis,” said Dugan W. Maddux, M.D., in December 2011. Maddux is the vice president of chronic disease initiatives at Fresenius Medical Care North America. In December last year, renal therapy company Fresenius was celebrating the 25 patients in its medical care facilities across the United States that would be reaching 100 years of age in 2012.

Trouble, however, wasn’t far behind. In March of this year, Fresenius issued an Urgent Product Notification warning to its customers that GranuFlo and NaturaLyte, both manufactured by Fresenius Medical Care, are associated with elevated bicarbonate levels, a significant risk factor for cardiac arrest. In June, the U.S. Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte Dialysis Products. Class I recalls are reserved for the most serious of cases, involving situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

GranuFlo and NaturaLyte are alkaline substance administered to dialysis patients to neutralize the acid that builds up in the blood. The products 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.

Despite the Class I recall, an FDA spokesperson has said that the officials will not require Fresenius to remove GranuFlo from the market entirely. The company is being required to re-label the product, and update operating manuals for dialysis machines.

According to a report by The New York Times, Fresenius circulated an internal memo to its clinics as early as November last year, warning that 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. The company conducted an analysis of these patients, comparing them to more than 80,000 other dialysis patients in the same centers. Overall, the data indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients. The memo recommended an adjustment of dialysis prescription for patients in the company’s own clinics, but did not notify other clinics or physicians until March when it released a “scientifically-ambiguous, two-page memo with far less actionable information” according to RenalWEB. The FDA has announced it is investigating the delay.

Though Fresenius notified employees internally, it did not notify the public or any regulatory bodies at the time. The company was prompted to come clean when the FDA approached it, following an anonymous receipt of the memo.

“One needs to question whether or not Fresenius had an opportunity to limit exposure to the solution earlier than it did,” Jeffrey S. Berns, M.D., of the University of Pennsylvania School of Medicine told New Jersey newspaper The Record. “I don’t really know that. I suspect that will be investigated.”

A statement released by Fresenius reads:

“MCNA will continue its process to place updated labels on its NaturaLyte and GranuFlo Acid Concentrate products, and to update its hemodialysis machine operator’s manuals. To date, FMCNA has notified more than 90 percent of its customers of these two labeling updates, and will continue with that effort until it is complete. The FDA’s action does not involve the removal of any FMCNA products from the marketplace.”

The company’s main office is in Germany, and its U.S. headquarters are located in Waltham, Mass.