Fresenius Medical Care ($FMS), one of the largest providers of kidney dialysis products and services, has landed in hot water with the FDA. Regulators are exploring whether the German company didn't inform its customers that a product used with its dialysis machines may drastically increase the risk of cardiac arrest if not used properly. Such an omission, if true, would be a violation of federal regulations.
The New York Times writes a detailed, intricate story that explores the issue, and in turn, credits RenalWEB, a website/blog focused on dialysis issues, with breaking the initial news. As the article notes, RenalWEB published an internal memo last month issued by Fresenius in November warning doctors at the company's dialysis centers of a large spike in patients who died abruptly from cardiac arrest, possibly from the improper use of its GranuFlo product as part of the procedure. GranuFlo is key here, because, according to the story, it contains an ingredient that the body converts to bicarbonate that is at a higher level than competing products. Bicarbonate, during the dialysis process, helps neutralize acid that builds up in the blood when kidneys don't work properly.
According to the November 4 memo, 941 patients treated in Fresenius clinics suffered cardiac arrest in 2010. And following an evaluation, Fresenius doctors determined that patients with high bicarbonate levels faced a cardiac risk that was 6 times higher than patients with lower levels of the alkaline substance in their blood. So the issue, in theory, is that doctors in those cases may not have been accounting for the surplus bicarbonate that GranuFo may generate when they determined how much bicarbonate to prescribe on their own. In short, a bicarbonate overdose is bad, and the NYT piece notes that previous studies suggest too much bicarbonate could be linked to heart trouble.
And to be fair, as the NYT notes, the Fresenius memo urged its doctors to address the matter quickly "in light of these troubled findings." At issue, though, is that Fresenius did not inform other, non-company centers using the product to treat thousands of additional patients until March, when the FDA began questioning the company after an anonymous individual sent it a copy of the internal memo.
Stephen Silverman, director of compliance for the FDA's Center for Devices and Radiological Health, told the NYT that he was "troubled by the fact that Fresenius on its own initiative didn't notify its entire customer base of this particular concern." He added that he saw the decision as "bad business" and "not in the interest of public health." What's more, the FDA may ultimately issue a warning letter to the Fresenius if it determines the company should have reported the safety concerns more widely.
Dr. Franklin Maddux, the chief medical officer for Fresenius' North American division, explained to the NYT that his office didn't have a way to communicate with clinics not affiliated with the company, other than through papers published in medical journals, but the memo findings were too preliminary to take that step yet. Maddux's office wrote the memo. A company spokesman told the newspaper that Fresenius' products division also didn't think a notice was necessary because the internal memo lacked any specifics about GranuFlo-related adverse events.
To be continued….
- read the NYT story (sub. req.)
- check out the initial RenalWEB posting