Citing serious injuries & side effects, the U.S. Food and Drug Administration (FDA) has announced a Class I recall of GranuFlo® a dialysis product used to clean the blood of patients undergoing hemodialysis for treatment of renal (kidney) failure.

Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.

Lack of Proper Instructions Put Dialysis Patients at Risk

GranuFlo® is the only dialysis solution product that contains the powder form of acetic acid, sodium diacetate. Having the powder available allows dialysis clinics to mix their own dialysate solution instead of paying more to ship and store 55-gallon drums of pre-mixed solution.

GranuFlo® is not inherently a dangerous product. However, the manufacturer’s incomplete mixing and administrating instructions made it dangerous and put dialysis patients at a higher risk of bicarbonate overdosing.

Manufacturer Neglected to Tell Physicians/Clinics About Problems

A November 4, 2011 internal memo issued by GranuFlo®‘s German manufacturer, Fresenius (FMC) indicated the company knew there was a significantly increased risk of cardiac arrest and death during hemodialysis treatments associated with GranuFlo®. The memo was sent ONLY to FMC’s own physicians and network of clinics. The memo reported 941 patients in 667 FMC facilities in 2010 had cardiopulmonary arrests during or soon after treatment while inside FMC’s clinics in 2010. All had six times higher levels of pre-dialysis bicarbonate level—a result that GranuFlo® causes.

This information was not shared with non-FMC physician/clinic customers, but was leaked to the FDA. In March, 2012—only after the company received an inquiry from the FDA about GranuFlo® —FMC provided a shorter version of the memo  to its non-FMC physicians/clinics customers. When the FDA recalled GranuFlo® on June 27, 2012, FMC issued a press release that same day characterizing the recall as a voluntary labeling change and noting that the FDA’s recall did not involve the removal of GranuFlo® from the marketplace.

GranuFlo® is used by more than a third of the estimated 400,000 hemodialysis patients at some 5,700 dialysis centers across the U.S. Total revenues from GranuFlo® sales per year in the U.S. are estimated at a minimum of $80 million.

Possible Serious Injuries and Side Effects

Too high bicarbonate levels caused by GranuFlo® can cause a variety of health problems for dialysis patients for up to two years following use. These include:

• Cardiopulmonary arrest
• Heart problems
• Metabolic alkalosis
• Low blood pressure
• Cardiac arrhythmia
• Sudden heart attack
• Stroke
• Death

If You Are a Physician or Clinic Who Uses Granuflo®

from From FDA Alert

Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.

Before writing the bicarbonate component of the dialysate prescription or using dialysate concentrates:

• Review the dialysate acid concentrate labeling for the specific concentrate that you prescribe or use to determine the components that can contribute to the patient’s bicarbonate level. The levels of acetate, citrate and/or acetic acid vary by product and manufacturer.
• Be sure to understand how your specific hemodialysis device proportions (mixes) the acid and base concentrates.
• Be aware that some dialysate acid concentrates contain acetate, citrate and acetic acid level combinations up to 8 mEq/L, and some products may contain both acetate and acetic acid.

 If you have used Granuflo® and have patients who suffered the conditions listed above or died, please join with us as we work to hold Fresenius responsible.

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