Product News and Recalls

FDA investigating dialysis company

The U.S. Food and Drug Administration is investigating whether Fresenius Medical Care, a German-based company that operates and supplies dialysis centers, sat on information suggesting that one of its products carries a potentially lethal risk, according to the New York Times.

Fresenius treats more than a third of the estimated 400,000 Americans who receive dialysis, and is also the country’s leading supplier of dialysis machines and disposable products. It maintains its own clinics, and provides products for other clinics as well.

Last November, according to the New York Times, Fresenius sent an internal memo to doctors practicing in the company’s dialysis centers, warning that failure to properly use a product called GranuFlo appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.

But the company waited until late March to warn other clinics that use Granuflo, and only did so after the F.D.A. received a copy of the internal memo from an anonymous tipster and questioned the company about it.

According to the report, an estimated 125,000 patients in non-Fresenius clinics are treated with GranuFlo.

Steven Silverman, director of compliance for the F.D.A.’s medical devices division, is quoted as saying: “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”

Dialysis removes toxic waste from the blood – a function ordinarily performed by the kidneys. That process involves providing the alkaline substance bicarbonate to neutralize acid that builds up in the blood.

GranuFlo, which performs different functions, contains a relatively high amount of an ingredient that the body converts to bicarbonate. The New York Times reports that many doctors apparently have not been accounting for this extra bicarbonate contribution from GranuFlo, resulting in an overdose that some recent studies have suggested could lead to heart problems.

The internal memo referred to 941 patients who had suffered cardiac arrest inside Fresenius clinics in 2010. The company’s medical staff concluded that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.

See the story here:

http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html