Fresenius Medical Care Recall: Did Company Trip Up?

Waltham, MAThe effectiveness of a regulator depends largely on the information it has at its disposal. To that end, the US Food and Drug Administration (FDA) more often than not must rely on the voluntary dissemination of information from manufacturers to properly and effectively regulate the industry for the benefit of the general public. A recent issue involving Dialysate Concentrates Hemodialysis serves to illustrate what can happen when important information is allegedly kept close to the vest.

Fresenius Medical Care AG is a provider based in Germany but operating as Fresenius Medical Care North America with US headquarters in Waltham, MA. In a press release issued this past June, Fresenius billed itself as the largest integrated provider of products and services for individuals requiring dialysis due to chronic kidney failure. Fresenius claims a network of 3,119 dialysis clinics throughout North America, Europe, Latin America, Asia-Pacific and Africa.

However, critics of Fresenius cite the manufacturer for less-than-stellar communication when problems with Alkali dosing errors due to higher-than-anticipated levels of bicarbonate posed a risk for some patients.

"Personally, I'm troubled by the fact that Fresenius on its own initiative didn't notify its entire customer base of this particular concern," said Steven Silverman, director of compliance for the FDA's medical devices division, in an interview with the New York Times in June (6/14/12). "Candidly, I just think it's bad business and not in the interest of public health to sit on information about risks."

Granuflo, the New York Times reported, performs various functions in the dialysis process and contains an active ingredient that the body converts to bicarbonate. As GranuFlo contains more of this ingredient than rival products, the result can be elevated levels of bicarbonate, which in turn can be a risk to the heart. Exacerbating the problem is when doctors—unaware of the elevated bicarbonate levels stemming from GranuFlo use—prescribe extra bicarbonate, which serves to elevate levels even further.

Such high levels of bicarbonate, it has been reported, can result in metabolic alkalosis, a risk factor for related to low blood pressure, hypokalemia, and cardiac arrhythmia which could lead to cardiopulmonary arrest, even death.

Fresenius issued a communiqué exclusively to doctors at Fresenius facilities last fall, noting that 941 patients suffered cardiac arrest in 2010 from GranuFlo use and related those incidents to the higher levels of bicarbonate.

Critics of Fresenius cite the company for failing to inform other facilities that may have been using Fresenius products for dialysis, and for failing to inform the FDA. As it turned out, the drug regulator was only brought into the picture after a copy of the November 2011 memo was leaked to the agency.

Not everyone is dumping on Fresenius equally. The Times published comments from Dr. Richard Ward, a professor of medicine at the University of Louisville, who noted the GranuFlo label provides sufficient information for doctors to figure out how to adjust dosing appropriately. "There are a lot of people who have a responsibility here in using a product how it is meant to be used," he said. "To dump all the responsibility on the manufacturer is not quite right."

In defending Fresenius, Dr. Franklin W. Maddux, the chief medical officer for Fresenius in North America which authored the 'Dear Doctor' memo for practitioners working at Fresenius facilities, noted in comments appearing in the New York Times that the company had no clear way of communicating with non-Fresenius customers outside of publishing a notice in medical journals. Maddux also said that in his view, the findings contained in the Fresenius memo were too preliminary to warrant publication.

But not everyone agrees. Dr. Thomas F. Parker III, chief medical officer at Renal Ventures, a dialysis chain that uses Fresenius products, had this to say: "If the data was sufficient to warn [Fresenius] doctors, then all users of the product should have been made aware of it," he said.

The FDA's response, once the agency was brought up to speed, was to issue what is deemed as one of the most serious responses the FDA has under its mandate—a Class 1 recall related to lots of GranuFlo and Naturalyte manufactured from January 2008 through June of this year.