During the advanced stages of kidney disease, the vital organs are no longer able to do their job, which is to remove toxins, like acids, out of the blood stream. Patients at this level of kidney disease often opt for dialysis, a medical treatment in which blood is pumped out of the body and cleaned of the acids that have built up in the blood stream. The toxins are washed away with the help of chemical solutions, like bicarbonate, that work to neutralize the acid levels in the blood. Once toxin-free, the blood is then pumped back into the body.
In 2003, the U.S. Food and Drug Administration approved the use of GranuFlo Dry Acid Concentrate, as well as its liquid counterpart NaturaLyte, for use in dialysis treatments. Both chemicals, manufactured by Fresenius Medical Care, contain higher-than-normal levels of bicarbonate, which when mixed with other medicines containing bicarbonates, can lead to an overdose situation resulting in various types of serious heart complications.
According to a report by the FDA, heart conditions that are likely to occur during an overdose include “low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest.”
In 2012, the FDA issued a recall on GranuFlo and NaturaLyte, deeming the products a Class 1 offense and labeling the medicine as having a high probability of causing adverse side effects or death.
If you or a loved one have experienced heart conditions following the use of GranuFlo while undergoing dialysis, contact our team of lawyers to help assert your legal rights.