FDA Issues Additional Warnings to Health Care Providers on GranuFlo Recall

In May 2012, the U.S. Food and Drug Administration (FDA) issued a recall notice for NaturaLyte Liquid Acid Concentrate and GranuFlo (powder) Acid Concentrate. Both products are dialysates, which are used during the dialysis process to clean a kidney patient’s blood and restore electrolyte balance – tasks the kidneys would carry out if they were working properly.

While other dialysates remain on the market and in regular use, NaturaLyte and GranuFlo were recalled because of their connection to an increased risk of heart attack, stroke, and other life-threatening conditions in patients exposed to them.  Many of these serious injuries resulted from an excessive concentration of bicarbonates in the blood, and many patients sought the help of experienced Kentucky GranuFlo injury attorneys to protect their legal rights after serious harm occurred.

Bicarbonates are used to maintain electrolyte balance in kidney patients.  Some of the compounds in dialysates turn to bicarbonates in the bloodstream, but patients may also be prescribed bicarbonates to take separately from their dialysis treatments.

The FDA’s recall notice for GranuFlo and NaturaLyte was accompanied by an advisory to medical professionals to examine the dialysates they use to treat patients. Dialysates high in acetic acid, acetate, and/or citrate may increase the risk of raising bicarbonate levels in the bloodstream, which in turn can cause injuries if the amount of bicarbonate increases to unsafe levels.  The FDA specifically advised healthcare providers to examine the labeling of the dialysate used to treat each particular patient and to consider whether the patient was also taking bicarbonates separately in order to determine if a particular dialysate was appropriate for that patient.