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Monday, 22-Apr-2013 19:03 Email | Share | | Bookmark
FDA Classifies GranuFlo, NaturaLyte Recall Under Class I

 
The GranuFlo and NaturaLyte recalls in the United States have been reportedly classified as a “Class I recall” by the United States Food and Drug Administration, according to online news reports. The category, being the most serious type of recall, indicates the risk of possible serious health problems or death from the use of both medications.

GranuFlo and NaturaLyte are dialysis concentrates developed and sold by Fresenius Medical Care (FMC), the leading provider of dialysis treatment. They are used in conjunction with bicarbonates and a dialysis machine during dialysis treatment in Fresenius clinics and other non-company dialysis centers. A dialysis treatment is designed to replace kidney functions in patients with renal failure, kidney diseases, and chronic kidney failure.

The Class I recall was reportedly implemented by the FDA after both products have been reportedly associated with high rates of serious heart problems and mortality risks in kidney disease patients under dialysis treatment using either GranuFlo or NaturaLyte dialysis concentrates. In comparison to other dialysate concentrates, both medications reportedly contained more of an ingredient that the body converts into bicarbonate. 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. It was later discovered by the company's medical staff that that the sharp increase in risk of cardiac arrest was linked to high levels of bicarbonate in patients’ blood. While such information circulated within the company’s own dialysis centers, other non-company clinics have not been notified until the information has reached the FDA through an anonymously-sent memo, reportedly drawing inquiry from the federal agency and resulting to a number of dialysis injury legal claims against the world’s leader in dialysis treatment.

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 agency urges physicians to closely monitor bicarbonate levels in patients and adjust dosing whenever deemed appropriate, and alerts nephrologists of the potential fatal repercussions of inaccurate bicarbonate dosing.



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


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