According to recent reports, more than half of all dialysis patients in the United States have received either GranuFlo or NaturaLyte treatments. People treated with these widely used dialysis drugs are also six times more likely to suffer cardiopulmonary arrest and sudden cardiac arrest.
Due to the serious risks associated with GranuFlo and NaturaLyte, the FDA issued a Class 1 recall, the most severe of all recall categories. The Class 1 recall indicates that the use of these dialysis drugs imparts the “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”. The company responsible for the manufacturing of GranuFlo and NaturaLyte, Fresenius Medical Care (FMC), has been notified by the U.S. Food and Drug Administration (FDA) that these popular dialysis treatments must be recalled immediately.
Fresenius Medical Care is the largest dialysis products and services manufacturer in the U.S., with more than 5,700 dialysis centers treating over 400,000 dialysis patients across the country.
Side Effects of GranuFlo and NaturaLyte
The following are some of the most commonly seen side effects documented from using GranuFlo and NaturaLyte:
- Low blood pressure
- Heart attack
- Cardiac arrhythmia
- Cardiopulmonary arrest
- Cardiovascular death
- Sudden cardiac death
Medical studies point to cardiac-related incidents as the leading cause of death in dialysis patients today.
Fresenius Medical Care Keeps Health Risks Under Wraps
Across the country, approximately 900 deaths have been attributed to GranuFlo and NaturaLyte. Between January 1st and December 31st of 2010, the Fresenius Medical Care (FMC) piloted an internal case-control study to determine what risk factors faced cardiopulmonary arrest patients in FMC facilities when compared to patients not treated by FMC.
Both products were found to have extremely high bicarbonate levels, connecting these dialysis treatments to severe health risks. And though the study, which took place in 2010 and focused on 841 cardiopulmonary arrest deaths of patients being treated in 667 FMC facilities, the FDA was not informed of its results until March 29, 2012.