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Investigation Continues on GranufloFresenius Medical Care

Filed January 17th, 2013 admin

GranufloFresenius Medical Care continues to be under investigation for failing to inform the public of a potentially deadly heart risk associated with high doses of the company’s NaturaLyte and GranuFlo dialysis products.

Fresenius is the largest operator of hemodialysis clinics in the United States and is also the country’s leading supplier of dialysis machines and disposable products and supplies. The U.S. Food and Drug Administration (FDA) believes that most patients receiving dialysis are under the impression that the medication they are getting is completely safe and, therefore, are unaware of the specific names of the products they are using during treatments. Also, since many facilities use local names, it is possible that some dialysis patients are not even aware that their medication comes from a Fresenius Medical Care afflicted facility.

Glanflo and Naturalyte can contribute to elevated bicarbonate levels in patients, which can result in hemodialysis metabolic alkalosis, a major risk factor in heart and health problems. Some of the side effects people receiving this dialysis at are risk for include: Sudden cardiac arrest, sudden heart attack, hemodialysis cardiac arrest, stroke, arrhythmia, confusion, low blood pressure, and death.

An internal company memo sent to doctors operating in its own clinics, dated November 4, 2011, warned that 941 patients had suffered from cardiac arrest inside Fresenius clinics in 2010. The memo stated that the failure of doctors to use GranuFlo and NaturaLyte correctly appeared to play a role in the increase of patient deaths. The company failed to report any type of warning to the general public until March 2012. The decision came only after the FDA received a copy of the company memo and questioned Fresenius about it.

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