Reuters: Regulatory News: UPDATE 1-FMC on US regulator's radar over dialysis - report

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UPDATE 1-FMC on US regulator's radar over dialysis - report Jun 15th 2012, 15:37 Fri Jun 15, 2012 11:37am EDT * FMC cld face scrutiny for not telling clinics of drug risks-NYT * Official quoted saying he was troubled FMC only warned own clinics * Co says memo based on preliminary findings * Says meant to prompt further fact-finding within company FRANKFURT, June 15 (Reuters) - Fresenius Medical Care (FMC) could face scrutiny from U.S. regulators for failing to alert dialysis clinics of risks linked to one of the drugs sold by the company, the New York Times reported. A spokesman for FMC, based at the group's German headquarters, said on Friday the memo was based on preliminary findings and was meant to prompt further fact-finding within the company. The FDA's March request was informal and subsequent talks led to FMC informing all clinics, he added. "There is no formal investigation by the FDA and we have no indication that there will be one," the spokesman said. In its online edition, the paper cited a U.S. Food and Drug Administration official as saying he was "troubled" that FMC only warned its own clinics of a link between its GranuFlo drug for dialysis patients and a higher risk of deadly cardiac arrest during the drug cleansing procedure. FMC operates about a third of all U.S. dialysis centres for patients with kidney failure, but it also supplies dialysis machines and drugs to rival clinic operators there and in Europe. The company, which makes almost two thirds of its revenues in North America, is controlled by German healthcare conglomerate Fresenius SE & Co. KGaA. In a Nov. 4 memo to FMC's U.S. doctors, the company said statistics point to doctors giving too much GranuFlo to some patients, triggering cardiac arrest, the newspaper said. "In light of these troubling findings," doctors should dose more carefully, according to the memo, which also said that "this issue needs to be addressed urgently". Fresenius, did not alert non-FMC centres until late March, after the FDA anonymously received a copy of the internal memo and questioned the company about it, the Times reported. The paper cited Steven Silverman, director of compliance for the FDA's medical devices division, as saying he was "troubled by the fact that Fresenius on its own initiative didn't notify its entire customer base of this particular concern". The chief medical officer for FMC in North America, Franklin W. Maddux, told the paper the findings of the internal memo were too preliminary to warrant a publication. Link this Share this Digg this Email Reprints

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