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dosing instructions 5 articles

Fresenius may open new dialysis clinic in Louisiana despite AG’s lawsuit

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is proposing to build a new dialysis center in Terrytown, La., despite being slapped with a lawsuit by the state’s Attorney General earlier this month. Fresenius owns nearly 100 dialysis clinics in Louisiana. The company uses its brand-name products in its facilities and also sells them to non-Fresenius-owned clinics. The state’s lawsuit claims that Fresenius’s dialysis concentrates GranuFlo and NaturaLyte caused patients to suffer from injuries including sudden cardiac arrest, and that the company violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents by ... Read More

Recent actions call into question whether Fresenius cares about patient safety

Recent actions by Fresenius Medical Care suggest the world’s largest provider of dialysis products and services may not be too concerned about patient safety. One example is the case of Robert Hiller. In January, he filed a lawsuit against Fresenius alleging he was wrongfully fired for simply doing his job of putting “into effect the company’s manufacturing practices to ensure that they were safe and complied with federal and state laws.” He alleged that in 2010 he first raised concerns whether certain practices where harming the purity of some of the products, but Fresenius officials initially dismissed his concerns. He was ... Read More

Fresenius delayed warning of deadly side effects from dialysis products GranuFlo, NaturaLyte

When Fresenius Medical Care, the world’s largest provider of dialysis products and services, issued a recall in March 2012 of its dialysis products GranuFlo and NaturaLyte in order to update dosing instructions on the safety labels, the company had known for months that the instructions were confusing and could lead to potentially deadly unintended overdoses of bicarbonate. According to RenalWEB, Fresenius management was first clued in to a possible connection between dosing errors with GranuFlo and cardiovascular-related deaths in dialysis patients as early as April 2009, during a 4-day professional conference. At that meeting, sudden cardiac death was identified as ... Read More

Dialysis giant Fresenius appoints new US CEO amid controversy surrounding GranuFlo

The Supervisory Board of German-based Fresenius Medical Care, the world’s largest provider of dialysis products and services, has appointed Ronald Kuerbitz as Chief Executive of its North American unit. Kuerbitz will succeed Rice Powell, the current CEO of the U.S. unit. Powell will assume the role of Fresenius Medical Care’s CEO and Chairman of the Management Board. As head of the U.S. unit for Fresenius, Kuerbitz will be forced to address a major red flag that came to light in March. That is when the Food and Drug Administration (FDA) received an anonymous copy of an internal memo the company ... Read More

FDA panels review children’s acetaminophen dosing instructions

Two Food and Drug Administration (FDA) advisory panels are reviewing medicines containing acetaminophen to determine if the dosing instructions should be updated to include information on treating infants under the age of 2 in order to protect them against overdose and possible liver failure and death. Over-the-counter acetaminophen medicines, which include the popular Children’s Tylenol, have instructions for use in children ages 2 and older, but for infants younger than 2 the instructions simply say to contact a doctor. Those instructions have remained somewhat unchanged since the 1970s. For infants, acetaminophen is used to reduce fevers over 100.4 and higher. ... Read More