Fresenius Medical Care manufactured GranuFlo and NaturaLyte dialysate to be used for dialysis in patients suffering from chronic kidney disease and renal failure. The Food and Drug Administration (FDA) approved GranuFlo in 2003 through a process called 510(k) of the Food, Drug, and Cosmetic Act. In this process, a premarketing submission is made which says that the device is substantially equivalent to a drug already placed on the market.
GranuFlo, a dry acid concentrate, in the form of powder is used as a chemical component of kidney dialysis to treat acute renal failure and chronic kidney disease. It contains both acetic acid and sodium citrate.
NaturaLyte is the liquid form of the same medication and comes as liquid hemodialysate concentrate. The liquid is used in a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
When patients are given incorrect doses, the side effects of GranuFlo and NaturaLyte increase significantly. Reports indicate that hundreds of patients suffered GranuFlo side effects caused by excessive bicarbonate levels, which were underestimated by many medical professionals. One of the major side effects is metabolic alkalosis.
Food Machinery Corporation (FMC) Corporation, an American chemical manufacturing company, released an urgent internal memo to more than 1,800 FMC clinics in 2011. The report suggested that 941 patients in 2010 suffered cardiac arrest and other GranuFlo side effects after receiving dialysis treatment in an FMC clinic. It also emphasized the importance of proper dosing to patients. However, the company is being accused of misconduct as they notified its own clinics but failed to notify the FDA or the thousands of other facilities that administered GranuFlo and NaturaLyte.
In 2021: The U.S. Food and Drug Administration (FDA) received an anonymous internal memo that hinted despite having prior knowledge regarding the risks associated with the use of its products used in dialysis, Fresenius failed to share the information with the public. Fresenius' physicians were advised through the memo of cardiac arrest risk in patients due to too much bicarbonate or carbon dioxide in the blood, a condition called metabolic alkalosis related to the improper use and dosing of Granuflo and Naturalyte during dialysis treatment. The memo was distributed internally on November 4, 2011, before the anonymous disclosure was made to the FDA and other dialysis centers using Fresenius' products.
Common Side Effects Of GranuFlo:
- GranuFlo and NaturaLyte when administered adequately under normal conditions is not known to cause side effects apart from the normally encountered symptoms.
- The doses, if administered inaccurately, can cause severe side effects, which include an excess of bicarbonate in the bloodstream, which can result in potentially deadly conditions like metabolic alkalosis.