GranuFlo and NaturaLyte are used in dialysis treatments for patients who suffer chronic and acute renal failure. GranuFlo has gained wide popularity since its release in 2003. However, a number of potentially fatal GranuFlo side effects have been reported from patients. In 2010, GranuFlo manufacturer Fresenius Medical Care (FMC) reported 941 cases of cardiac arrest as NaturaLyte and GranuFlo side effects. Other GranuFlo side effects include metabolic alkalosis and low blood pressure.
How GranuFlo Works
GranuFlo is a powdered acid concentrate that is mixed with other components to form a solution called dialysate. NaturaLyte is a very similar product in liquid form. Dialysate is then used in dialysis treatment. During dialysis treatment, the patient’s blood is removed from the body, filtered, then returned to the body. Dialysis treatment performs the function that is usually performed by the kidneys. However, patients with renal disease suffer kidney problems that make them unable to filter the blood naturally.
Patients with renal disease typically experience increased acid levels in the blood. This is a result of the kidneys’ inability to naturally filter out bodily acid. Dialysis treatment uses bicarbonate to neutralize the patient’s blood acid levels. However, bicarbonate levels should be carefully monitored during dialysis treatment. Excessive bicarbonate during treatment can cause life-threatening GranuFlo side effects.
GranuFlo Dosing Errors
Evidence showed that NaturaLyte and GranuFlo side effects increased significantly if patients were given incorrect doses. Reports indicate that many medical professionals underestimated the levels of bicarbonate that occur from GranuFlo and NaturaLyte treatment. As a result, hundreds of patients suffered GranuFlo side effects caused by excessive bicarbonate levels. Among the most dangerous of the GranuFlo side effects is metabolic alkalosis.
In 2011, FMC released an urgent internal memo to more than 1,800 FMC clinics. This memo reported that 941 patients in 2010 suffered cardiac arrest and other GranuFlo side effects after receiving dialysis treatment in an FMC clinic. Within the memo, FMC emphasized the importance of proper dosing to patients. However, the company is being accused of misconduct. While FMC notified its own clinics, it did not notify the FDA or the thousands of other facilities that administered GranuFlo and NaturaLyte.
FDA Warning for GranuFlo Side Effects
The internal FMC memo was anonymously leaked to the FDA. This prompted FMC to release a second memo to all clinics warning doctors and patients of GranuFlo side effects. In June 2012, the FDA issued a Class I recall on the products, citing the severe NaturaLyte and GranuFlo side effects.
GranuFlo Metabolic Alkalosis
Metabolic alkalosis is a GranuFlo side effect that signifies excess blood levels of base, or alkali. During this condition, the patient’s pH balance is elevated beyond normal. GranuFlo side effects from metabolic alkalosis can be fatal if the patient does not receive proper medical attention. In its most severe form, metabolic alkalosis can cause cardiac arrest, heart attack, and stroke. These conditions can cause death.
Patients suffering GranuFlo side effects from metabolic alkalosis may experience:
- Hand tremors
- Nausea and vomiting
- Muscle twitching
- Tetany, or prolonged muscle spasms
- Tingling or numbness in the hands, feet, or face
Warning signs of severe cardiovascular GranuFlo side effects can be noted when a patient begins to experience arrhythmia, or irregular heartbeat. Episodes of apnea may also occur, where the patient stops breathing. During metabolic alkalosis, apneas may occur for 15 or more seconds. GranuFlo side effects can also cause inadequate oxygen intake in the patient. This can lead to cyanosis, or bluish-purplish skin discoloration.
GranuFlo side effects from metabolic alkalosis can also include:
- Hypoxemia, or low levels of blood oxygen
- Hypokalemia, or low levels of blood potassium
- Hypercapnia, or high levels of blood carbon dioxide