GranuFlo, NaturaLyte Placed Under Serious Recall Category by the FDA

The GranuFlo and NaturaLyte recalls in the United States have been reportedly placed under “Class I recall” classification by the United States Food and Drug Administration, according to online news reports. The category, being the most serious type of recall, warns of risk of possible adverse health consequences or death from the use of both medications. 

GranuFlo and NaturaLyte are dialysis concentrates manufactured and marketed by the Germany-based dialysis treatment provider, Fresenius Medical Care (FMC). They are used during dialysis treatment along with bicarbonates and a dialysis machine in Fresenius and other dialysis clinics. Dialysis primarily works to replace critical kidney functions in patients with renal failure, kidney diseases, and chronic kidney failure.

The Class I recall was reportedly issued by the FDA following reports of serious cardiovascular problems and death risks in dialysis patients have been associated with the use of either GranuFlo or NaturaLyte. Both drugs reportedly contained more of an ingredient that the human body converts into bicarbonate compared to other similar products. When used altogether with bicarbonate, the result may be, in effect, an overdose of bicarbonate, holding patients susceptible to risks of metabolic alkalosis, which in turn may lead to other health problems including low blood pressure, stroke, heart attacks, and even death, as has been reported by the federal agency in their recall report.

In addition, as many as 941 patients reportedly suffered from cardiac arrest while receiving dialysis treatment in Fresenius clinics two years ago, according to a New York Times report. The company later found out that such increase in the risk of patients facing fatality due to cardiac arrest may have been tied to high levels of bicarbonate in their blood. Although the company consequently sent an internal memo concerning these risks to its own dialysis centers, other non-Fresenius centers have not been reportedly informed until a copy of the memo has been sent anonymously to the FDA, reportedly putting the company under the microscope and prompting some patients or family members to lodge a dialysis injury suit against Fresenius.

Despite the recall, GranuFlo and NaturaLyte are still being marketed and used in dialysis clinics as the recall does not require both products to be removed from dialysis medical facilities. The FDA, on the other hand, urges physicians to frequently watch bicarbonate levels among patients and adjust dosing whenever necessary, and emphasizes the potential fatal risks of inappropriate bicarbonate prescription.

Sources:

• fda.gov/medicaldevices/safety/listofrecalls/ucm309990.htm
• nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0