Over 400,000 Americans are receiving dialysis.  Dialysis is a medical treatment that specifically takes place in the kidneys and clears toxic waste from the blood when the kidneys cannot.  Fresenius Medical Care, a company providing dialysis products, provides treatment in one form or another to more than 1/3 of these Americans.  Fresenius is no doubt a leading supplier of dialysis machines and also disposable products.  Now, the FDA (U.S. Food and Drug Administration is investigating this dialysis center, Fresenius Medical Care.  Specifically, the FDA is looking into whether the company violated federal regulations by neglecting to inform customer of risks – lethal risks – associated to one of its products.

This is a recurring problem – big companies failing to protect us.  Several months ago, Fresenius’ medical office forwarded an internal memorandum to internal company dialysis doctors.  The memo warned the doctors that proper product use was critical as improper use of a particular product was contributing to a dramatic increase in death from sudden cardiac arrest.  “This issue needs to be addressed urgently”, per the memo.  So while it was forward to warn the internal physicians, Fresenius failed to notice external centers using the dialysis product, GranuFlo.  Therefore, the company’s company base of dialysis patients, were not properly warned of the dangers.  Specifically, it is thought that over 125,000 patients were not warned.

GranuFlo contains a special ingredient that converts to bicarbonate.  Bicarbonate is an alkaline substance that helps our body neutralize acid that builds up in the blood.  GranuFlo has more of this special ingredient than other products – it is one of the product’s selling points.  The trouble is, many doctors prescribe additional bicarbonate separately.  So when the doctors were not made aware of this high ingredient amount, sometimes too much bicarbonate was resulting.  An overdose of bicarbonate can lead to heart and general cardiac problems.

Dr. Daniel Coyne, the director of hemodialysis at Washington University right here in St. Louis Missouri, has reported that 30% of his patients had high levels of bicarbonate.  Dr. Coyne said “a four to sixfold increased risk of in-center cardiac arrest if very concerning”.

a b