As lawsuits pile up against Fresenius N.A., the pharmaceutical company that manufactures the dialysis drug GranuFlo – implicated in the deaths of hundreds of patients – it's worth taking a look at exactly what is allegedly killing them.
According to the U.S. Food and Drug Administration (FDA), one culprit is metabolic alkalosis.
All systems – including the biosystems of living plants and animals – depend on a delicate balance that, if upset, may lead to grave consequences. In this case, it is the pH level of the blood – the balance between acidity and alkalinity. Metabolic acidosis is a condition in which a patient's blood is too alkaline, as if a huge dose of sodium bicarbonate (Tums) was injected into a vein or artery. When the patient's blood is too alkaline, the result can be a dangerous drop in blood pressure, as well as a loss of potassium (a necessary element in regulating muscle and nerve function), oxygen starvation, dangerous build-up of carbon dioxide in the blood and irregular heartbeat. All of these factors can contribute to cardiac arrest.
The issue at the center of the present litigation is whether Fresenius failed in its duty to sufficiently warn the medical community and patients about these risks with GranuFlo. The company did, in fact, issue warnings to its own clinics, but for some reason, decided that the evidence was “too preliminary” to warrant widespread dissemination. It wasn’t until an anonymous whistleblower reported the problems with GranuFlo to the FDA that Fresenius decided to warn the general public.
That decision may wind up costing Fresenius dearly – though not nearly as much as it cost the families of those whose loved ones died from complications caused by metabolic alkalosis.
N/A. “Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate.” Medical Device Recalls, 29 March 2012.
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