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Internal Granuflo Documents Targets by FDA

Published on Mar 12, 2013 at 1:49 pm in Dangerous Drugs.

The U.S. Food and Drug Administration (FDA) recently announced an investigation of Fresenius Medical Care due to concerns that the company failed to warn doctors and patients of the risks connected to its dialysate GranuFlo. The product has been linked to a quick increase in serious cardiac problems among dialysis patients and one that concerns many experienced Kentucky drug recall attorneys.

According to the New York Times, the FDA’s investigation focuses on whether or not Fresenius violated federal regulations by failing to warn patients of the potentially deadly risks related to GranuFlo use. The company sent an internal memo to doctors practicing in its dialysis centers warning them that improper GranuFlo use had been linked to cardiac arrest. However, the company did not warn its patients of the risk.

A company spokesperson said that because the doctors’ memo contained no reference to specific incidents in which actual patients had suffered harm, the company did not think warning patients was necessary at the time. The doctors’ memo did note, however, that 941 patients suffered cardiac arrest in 2010 during or after treatment in Fresenius clinics, and that comparisons of these patients to others had revealed that the patients had much higher bicarbonate levels in their blood than other patients. Fresenius issued a notice to patients about six months later, according to the Times article.

GranuFlo is a dialysate, a compound used during the dialysis process to clean the blood. Use of the product has been linked to an increase in bicarbonates in the bloodstream, which can produce cardiac arrest or other heart problems if concentrations are too high.