In recent months, the German pharmaceutical firm Frenesius has been taken to task over its dialysis drug, Granuflo, over allegations that the drug has caused patients to suffer heart attacks. This is caused by a number of conditions due to the fact that Granuflo contains a higher concentration of sodium diacetate than similar medications. Frenesius apparently failed to make doctors outside its own network of dialysis clinics aware of this. This “failure to warn” is at the heart of Granuflo lawsuits that have been filed over the past few years.
The news about Granuflo is well-known and has been widely covered in the media over the past several months. What is less well-known is that Granuflo isn't the only Frenesius product that has allegedly put patients' lives in danger. Recently however, the professional journal Nephrology News and Issues reported that the U.S. Food and Drug Administration has issued a Class I recall of Frenesius' 2008 Series hemodialysis machines as well.
Frenesius dialysis machines have a dismal history. Between October of 2010 and November 2013, the company's Liberty Cycler machines were plagued with a series of leaks that could lead to contamination. This in turn put patients at risk for peritonitis, a potentially serious inflammation of the inner lining that covers the internal organs.
The 2008 Series have a defect that causes saline bags to fill up “inappropriately...during setup and recirculation.
A “Class II recall” affects products that are known or suspected to cause health problems that are nonetheless treatable. The drug Granuflo was the target of a Class I recall, issued when a product may cause death.
While representatives for Frenesius continue to insist that company products still on the market are “safe” when used in accordance with instructions, Frenesius' recent history strongly suggests that the main concern here is profits, not patient safety.
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