GranuFlo, NaturaLyte Falls Under the FDA’s Highest Recall Category

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, indicates the risk of potentially serious health problems or death from the use of both medications.

GranuFlo and NaturaLyte are dialysis drug treatments manufactured and widely distributed by the world’s largest dialysis group, Fresenius Medical Care (FMC). They are used in conjunction with bicarbonates and a dialysis machine during dialysis treatment in Fresenius clinics and other non-company dialysis centers. Dialysis is indicated for patients with advanced renal dysfunction, kidney diseases, and chronic kidney failure.

The Class I recall was reportedly in view of an increase in risk of cardiac problems and mortality among kidney disease patients who had received dialysis treatment using either GranuFlo or NaturaLyte concentrates. In comparison to other dialysate concentrates, both medications reportedly contained more of an ingredient that the body converts into bicarbonate. When used with bicarbonates, an overdose of bicarbonate may ensue, which in turn may lead to metabolic alkalosis — a condition that has been associated with complications such as low blood pressure, stroke, heart attacks, and even death, as was indicated in the FDA recall report.

Furthermore, a New York Times report also revealed that more than 900 dialysis patients have reportedly suffered cardiac arrest inside Fresenius clinics in 2010. 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. This information, however, has not been sent to other non-Fresenius centers until the FDA anonymously received a memo, reportedly harboring close scrutiny from the agency and consequently eliciting a series of dialysis injury lawsuits against the leading dialysis treatment provider.

GranuFlo and NaturaLyte are still being sold and administered in dialysis treatments as the recall does not call for an all-out ban of its use in 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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