Pharmaceutical

Dialysis giant Fresenius appoints new US CEO amid controversy surrounding GranuFlo

dialysis Dialysis giant Fresenius appoints new US CEO amid controversy surrounding GranuFloThe 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 sent to its doctors notifying them that failure to properly use one of its products appeared to be contributing to a sharp increase in sudden cardiac death in patients – as many as 941 patients in Fresenius in 2010 alone.

The memo was meant to clarify dosing instructions for its most widely used dry acid product, GranuFlo. The concentrate contains an ingredient that the body converts to a substance known as bicarbonate that neutralizes acid in the body.

GranuFlo contains more of this ingredient than competitor products, and apparently doctors were not taking this into account when dosing GranuFlo. Patients were inadvertently overdosing on bicarbonate, which can cause heart problems including cardiac arrest.

Fresenius tried to keep the mix-up secret, but when the FDA got its hands on the internal memo, it questioned the company as to why it didn’t alert the agency or patients who were directly affected by the problem with GranuFlo as well as a similar product made by the company, NaturaLyte. The FDA also ordered Fresenius to recall its products and change labeling to clarify dosing instructions.

Both Kuerbitz and Powell will assume their new roles for Fresenius on January 1, 2013.

Sources:
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