FDA Investigates GranuFlo and Naturalyte Dialysis Products

August 22, 2012

The United States Food and Drug Administration is currently investigating the nation’s biggest dialysis operator, questioning whether they failed to inform their customers of potentially life threatening risks associated with its products GranuFlo and Naturalyte. Fresenius Medical Care, the makers of GranuFlo and Naturalyte treat more than one third of all Americans who receive dialysis.

This past November, Fresenius released an internal memo to its doctors operating inside its dialysis centers to warn them that improper use of the company’s products appeared to be causing a dramatic increase in the risk of patients dying from sudden cardiac arrest. The memo warned that the issues needed to be addressed urgently. Disappointingly, however, Fresenius failed to warn the broader public and did not mention these concerns to all of its dialysis centers.

Fresenius, maker of GranuFlo and Naturalyte, only warned its other centers and the public about these dangers after the internal memo was leaked to the FDA in March of the following year. Steven Silverman of the FDA remarked that he was, “troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”

Executives at Fresenius Medical Care continue to say that it was not their fault that they didn’t warn the greater population about the dangers of its products GranuFlo and Naturalyte. They say that they had no way of releasing that information to other dialysis centers except by publication and that their findings were too preliminary to release in that form.

Dialysis is a process that takes over the responsibilities of the kidneys in clearing waste from the blood. Part of the process involves adding bicarbonate (like GranuFlo or Naturalyte), an alkaline product in order to neutralize the acid buildup in the blood. GranuFlo and Naturalyte are meant to perform various jobs, but they has an ingredient which the body transforms to bicarbonate and they contain more of this than rivals.

Many believe that the cause of GranuFlo and Naturalyte dialysis deaths is that doctors are unaware of the increased levels of bicarbonate and have not been modifying their dosages. This may cause patients to overdose on GranuFlo or Naturalyte and cause severe and deathly heart conditions. The internal memo sent out at Fresenius discovered that more than 900 patients had suffered cardiac arrest inside its clinics during 2010 alone.

GranuFlo and Naturalyte Dialysis Lawsuit

If you or a loved one has experienced cardiac arrest, heart attack, stroke following dialysis with GranuFlo or Naturalyte, please contact the Willis Law Firm for a free consultation for a potential GranuFlo Dialysis Lawsuit or Naturalyte Dialysis Lawsuit. You may be entitled to financial compensation from the makers of Naturalyte in a Naturalyte dialysis lawsuit.

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