GranuFlo Users Susceptible to Cardiac Problems
There are more or less 125,000 patients who experienced dialysis treatment with the use of NaturaLyte or GranuFlo. Both products are manufactured by Fresenius and are used at several dialysis centers all over the United States. Because of the serious side effects the drugs may cause, the Food and Drug Administration issued a Class 1 recall for both medications. A Class 1 recall is categorized as the highest level of recall and is only used for drugs or medical products that cause major health problems and death. The main reason for the recall was due to the dialysates elevating bicarbonate levels in the patient’s body to the point where a condition called metabolic alkalosis can happen.
GranuFlo and NaturaLyte concentrates are used to treat chronic and acute renal failure during hemodialysis, wherein a machine filters salts, wastes, and fluids from the blood. This is done when the kidneys can no longer perform the essential bodily function.
Patients who suffer the negative effects are beginning to file individual GranuFlo lawsuit. Those who have used either NaturaLyte or GranuFlo during dialysis are prone to experience cardiac problems, like low blood pressure, irregular heart rate and heart attack. Other cardiac events include excessive carbon dioxide in the blood, low blood pressure and low potassium and oxygen in the blood. Patients also have increased chances of having a stroke.
The Food and Drug Administration (FDA) received reports that Fresenius knew about the possible side effects but withheld the information. In fact, an internal memo has been sent to doctors at Fresenius clinics noting that 941 Fresenius patients have suffered heart attacks after using GranuFlo or NaturaLyte. Fresenius failed to inform customer hospitals and clinics of the fatal risk linked to their dialysis products. The FDA is investigating whether Fresenius has violated federal regulations by only informing clinics belonging to their group.