Thursday, June 21, 2012
Gfanuflo and NaturaLyte News
There is news about metabolic alkalosis with Fresenius Medical Care’s GranuFlo and NaturaLyte dialysis products , which can lead to heart problems and other potentially fatal complications. According to the New York Times, the company acknowledged the dangers in an internal memo last year, but failed to disclose the information to the FDA, its consumers or the public. [nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?emc=tnt&tntemail0=y]
Dialysis is a procedure that replaces the function of the kidneys by filtering toxic waste products out of the blood; a number of different solutes are used to maintain a healthy balance. One of these substances is bicarbonate, an alkaline chemical used to neutralize any excess acidity in the blood. According to the New York Times, the issue with GranuFlo and NaturaLyte is that they produce more bicarbonate than their competitors, which may lead to excessively high alkaline levels, or metabolic alkalosis. Metabolic alkalosis can increase the risk of serious complications, such as:[medicinenet.com/hemodialysis/article.htm]
Fresenius Medical Care addressed these risks in an internal memo dated November 4, 2011, but did not warn its consumers or the public about the issue until March, after it was questioned by the FDA. The memo stated that 941 patients experienced cardiac arrest in Fresenius clinics in 2010, and found that that elevated bicarbonate levels resulted in a six fold increased risk of cardiac arrest. “In light of these troubling findings” doctors should adjust blood alkalinity accordingly, the memo said.