FDA Investigates GranuFlo Dialysis Risks
The FDA is investigating why Fresenius Medical Care did not warn all dialysis centers that its product, GranuFlo, could cause cardiac arrest when used improperly.
Improper use of GranuFlo during dialysis could increase a patient's risk of cardiac arrest by four to six times. The discovery prompted Fresenius Medical Care (FMC), maker of GranuFlo, to send a memo warning doctors at its nationwide centers. However, the FDA is investigating why Fresenius did not send a similar memo to other centers that use its product until five months later, and if this delay could have injured patients.
About the Study
- The study, conducted by Fresenius Medical Care, looked at 941 people who suffered cardiac arrest in FMC dialysis centers in 2010.
- Patients with high levels of bicarbonate in their blood had four to six times the risk of suffering cardiac arrest during dialysis.
Misuse of GranuFlo
- GranuFlo contains higher concentrations of a compound that creates bicarbonates in the blood than do similar dialysis products.
- Because of this higher concentration, doctors should modify standard bicarbonate prescriptions.
- The Nov. 2011 memo sent by Fresenius warned that doctors might be giving too much GranuFlo to some patients, triggering cardiac arrest.
- Fresenius only sent this memo to doctors working in its own clinics. Doctors using GranuFlo in outside clinics received a shorter memo in March 2012 after the FDA contacted Fresenius.
- Anyone who received GranuFlo during dialysis and suffered cardiac arrest, death, or heart damage might have been affected.
- The FDA has reported that it is “troubled” that Fresenius did not warn outside dialysis centers on its own initiative. FMC's original memo said the GranuFlo issue “needs to be addressed urgently.”
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