GranuFlo Recall Informs Dialysis Patients Of Potential Risks

by Terry Bryant

Being one of the most popular and widespread drugs used in dialysis, the GranuFlo recall certainly surprised and shocked many individuals with renal disease (kidney failure).  Occurring in March of 2012, the US Food & Drug Administration announced an official Class 1 recall of the drug, indicating that the drug has been deemed potentially deadly to those taking it.

The substance is a dry acid concentrate, which is a precursor ingredient in making dialysate—the compound necessary to perform dialysis. The drug, touted by its manufacturer Fresenius as revolutionary, was seen as such because it took up far less space when stored in bulk in dialysis clinics. This is because it was concentrated in a higher degree than other drugs on the market. However, this attribute also turned out to be its downfall.

Due to failing to properly warn medical professionals of this, patients subjected to dialysis with this chemical often ended up with dangerously high levels of bicarbonate. Bicarbonate is considered a “buffer chemical” that helps keep the pH level of blood normal—not too acidic or basic. With too high a bicarbonate level, patients are put at serious risk of cardiac failure.

The GranuFlo recall was based largely on a leaked internal memo, originally intended just for those within the Fresenius Medical Care.  In medical jargon, the memo essentially stated that the bicarbonate levels were often higher than normal and also stated that in the year 2010, 941 patients had a cardiac arrest episode after their dialysis treatment (just in Fresenius-operated dialysis clinics). By not making this information available to anyone potentially afflicted, the organization displayed carelessness and unnecessarily risked lives.

Many people affected by this medication have opted to file a GranuFlo lawsuit against the manufacturer.