Did Fresenius Withhold Knowledge of GranuFlo Side Effects?
What are GranuFlo Side Effects?
Granuflo. Aside from hearing it mentioned during just about every other commercial break, there probably isn’t much else you know about it. That’s because it’s one of several chemicals used in dialysis.
The U.S. Food and Drug Administration (FDA) approved Granuflo in 2003. It’s manufactured by Fresenius Medical Care (FMC), a major player in the dialysis market in the U.S. It’s estimated that 400,000 Americans who suffer from kidney disease or renal failure undergo dialysis treatment several times a week and half of these people are administered Granuflo or its counterpart Naturalyte.
As a chemical used in dialysis, Granuflo is designed to treat renal failure and chronic kidney disease. Renal failure and kidney disease leave the body in capable of filtrating harmful substances from blood. Diabetes is one of the leading causes of renal and kidney failure.
Dialysis is the process in which the filtration of harmful substances is simulated. Unfortunately, Granuflo and Naturalyte often cause an excess of bicarbonate in the bloodstream, which leads to metabolic alkalosis. Bicarbonate itself is a buffer in the blood which prevents blood from becoming too acidic.
What Are Those Potentially Lethal Side Effects?
Granuflo side effects at their worst lead to death, but may also include: low blood pressure, cardiac arrest, irregular heartbeat, lowered blood oxygen and lowered blood potassium among other things.
The chemical’s manufacturer, Fresenius Medical Care, recognized in 2011 the harmful potential of Granuflo side effects and informed doctors internally. The memo noted that in 2010, 941 patients administered Granuflo or Naturalyte suffered cardiac arrest. FMC did not send this memo to non-FMC clinics and allegedly failed to notify the FDA.
Granuflo was recalled in March of 2012 after the FDA questioned FMC about the side effects associated with the chemical. The recalls were a Class 1 which is the most serious and alerts the public of the negative health reactions and the possibility of death. Unfortunately the recall did not require that Granuflo or Naturalyte be removed from the clinics. Instead it warned doctors of inaccurate dosage dangers and required that the proper dosing procedure and label be updated accordingly.
The number of Granuflo side effects lawsuits is growing. Some of the lawsuits being filed are upwards of $6 million. If you or a family member experienced any of the Granuflo symptoms mentioned, you could seek compensation for: lost wages, future medical expenses, reduced quality of life or emotional suffering. A Granuflo lawyer could help you file a claim for: negligence, pain and suffering or punitive damages.
If you’re unsure whether you or a loved one received Granuflo, you can check with you dialysis center or physician. Your medical records should show what products you’ve used and how long you’ve used them for.