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US Regulators “Troubled” by FMC Failure to Alert Dialysis Clinics of GranuFlow Heart Risks

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The New York Times has reported that Fresenius Medical Care (FMC) has “troubled” U.S. Food and Drug Administration officials by warning its own clinics about a link between the dialysis drug GranuFlo and an increased risk of cardiac arrest, while failing to warn all other clinics to which it supplies the drug.

According to the paper, FMC operates nearly one-third of all dialysis centers in the United States, however, it supplies drugs and equipment to clinics across North America and Europe. FMC sent a memo in November to its own clinics saying that physicians were giving some patients too much GranuFlo, causing cardiac arrest, however, the company did not notify non-FMC clinics about the heightened risks until the following March. In the memo, FMC wrote that “these troubling findings” need to be “addressed urgently.”

The New York Times reported that FDA director of compliance for the medical devices division, Steven Silverman, said that he was “troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”

 

breakinglawsuitnews.com disclaimer: This article: US Regulators “Troubled” by FMC Failure to Alert Dialysis Clinics of GranuFlow Heart Risks was posted on Friday, June 15th, 2012 at 4:39 pm at breakinglawsuitnews.com and is filed under Defective Drug Lawsuits.

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