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Fresenius Dialysis Under Scrutiny Following Deaths

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Fresenius Dialysis is facing scrutiny following reports of deaths linked to drugs used in its clinics. Media outlets, The New York Times and Reuters, write that Fresenius Medical Care (FMC) allegedly neglected to advise dialysis clinics of risks linked to a Fresenius medication, GranuFlo. According to The Times, a U.S. Food & Drug Administration (FDA) official said he was “troubled” that Fresenius only advised its own clinics about the link between dialysis drug GranuFlo and increased risks for fatal cardiac arrest during dialysis, said Reuters. FMC operates about 30% of all dialysis centers in the United States; however, it also provides both dialysis machines and medications to rival clinic operators in the U.S. and Europe, said Reuters. Fresenius Medical Care, controlled by Fresenius SE & Co. KGaAm, makes the bulk of its revenue—about 2/3rds, said Reuters—in North America. FMC is the nation’s largest dialysis center operator. In a November 4th memo sent to its U.S. physicians, Fresenius stated that, according to statistics, doctors are overdosing some patients with GranuFlo, which is triggering heart attack, wrote Reuters. “In light of these troubling findings,” the memo said, doctors should dose more carefully, adding that “this issue needs to be addressed urgently.” Despite the so-called urgency, Fresenius never alerted nonFMC centers until late March and, then, only after the FDA received a copy of the memo from an anonymous source, said Reuters. According to

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The Times, the FDA’s director of compliance for its medical devices division, Steven Silverman, questioned Fresenius about the memo saying he was “troubled by the fact that Fresenius, on its own initiative, didn’t notify its entire customer base of this particular concern.” In kidney failure patients, dialysis removes toxic waste from the blood, which involves providing an alkaline bicarbonate to neutralize acid build-up, explained The Times. While GranuFlo is used for different functions, it contains an ingredient the body converts to bicarbonate, and contains more of this ingredient than competitor products. Unaware of this, doctors have not been taking the extra bicarbonate into consideration when using GranuFlo and determining how much bicarbonate to separately prescribe for dialysis. This can lead to bicarbonate overdose, said The Times, which, say some studies, could lead to serious cardiac problems. In fact, Fresenius’ memo indicated that in 2010, 941 patients suffered cardiac arrest in Fresenius clinics. Fresenius’ medical staff concluded that patients with increased blood bicarbonate levels were at a six-fold risk of suffering cardiac arrest, versus patients with lower bicarbonate levels, said The Times. FMC’s North American Chief Medical Officer (CMO), Franklin W. Maddux, told The Times that the memo’s findings were too preliminary to warrant publication. Meanwhile, the FDA, said The Times, is investigating if Fresenius violated federal regulations by not advising customers of the potentially deadly GranuFlo risk. The FDA could issue a warning letter to Fresenius if the agency finds FMC should have reported the safety concerns, said The Times. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks,” said Silverman. The CMO of Renal Ventures, Dr. Thomas F. Parker III, told The Times that “If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it.” Renal Ventures is a dialysis chain that uses Fresenius products. FMC”s Maddux disagreed saying that his office—which is from where the memo originated—only managed FMC’s own centers and was unable to advise nonFMC clinics except via papers in medical journals. “I felt that it was not in a condition for general consumption,” he said in an interview, wrote The Times. The product division at Fresenius, which sells GranuFlo, could have advised customers but a company spokesman said it did not believe a notice was called for since the internal memo never discussed specific GranuFlo-linked adverse events. The matter was first reported by web site RenalWEB, which is focused on dialysis. According to the site, said The Times, some 125,000 patients are treated with GranuFlo in nonFresenius clinics. Dr. Daniel Coyne, director of hemodialysis at Washington University in St. Louis, told The Times that 30 percent of his center’s patients had blood bicarbonate levels that were too high. “A four- to six-fold increased risk of in-center cardiac arrest is very concerning,” Dr. Coyne wrote in an email to The Times. “My partners are all trying to figure out a fix to this problem.”

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