GranuFlo and NaturaLyte Side Effects
GranuFlo and NaturaLyte, used in dialysis, can cause serious health issues like alkalosis and low potassium, leading to heart attacks, strokes and even death. Proper monitoring and individualized treatment are crucial for patient safety.
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- Last Modified: October 22, 2024
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- Manufacturer
- Fresenius Medical Care
- Common Side Effects
- Alkalosis, low potassium levels (hypokalemia), electrolyte imbalance, low blood pressure (hypotension) and low oxygen levels (hypoxemia)
- Serious Side Effects
- Heart attacks, cardiopulmonary arrest, strokes, irregular heartbeat and kidney failure
Alkalosis and Low Potassium
Alkalosis and low potassium levels are both possible with GranuFlo and NaturaLyte. Each can cause further severe and life-threatening complications.
Alkalosis is a significant risk factor for patients using GranuFlo and NaturaLyte. This condition is characterized by an excessively high blood pH, causing the blood to be too alkaline. GranuFlo contains sodium acetate, which your body rapidly converts to a chemical called bicarbonate. High bicarbonate levels can lead to alkalosis, which is associated with cardiopulmonary arrest and other serious complications. Cardiopulmonary arrest is the sudden loss of heart and lung function.
“My major concerns with NaturaLyte and GranuFlo include risks of metabolic alkalosis as well as associated cardiovascular complications,” Dr. Michael McKinney, with medical weight loss center Healthy Outlook, told Drugwatch.
“I pay close attention to electrolyte concentrations and blood pressure levels in patients on dialysis to minimize cases such as hypotension and imbalances in electrolytes.”
Researchers writing in Seminars in Dialysis studied hemodialysis patients over ten years. They found that older patients with high bicarbonate levels had more heart issues and lower blood pressure during dialysis. These patients were more likely to have persistent alkalosis, which could lead to serious heart problems.
- Confusion
- Hand tremors
- Light-headedness
- Muscle twitching
- Nausea
- Prolonged muscle spasms
- Vomiting
Low potassium levels, or hypokalemia, often accompany alkalosis in dialysis patients. An internal memo from Fresenius, the manufacturer of GranuFlo and NaturaLyte, noted that patients with low potassium and high bicarbonate levels had an even greater risk of cardiopulmonary arrest.
Hypokalemia can cause muscle weakness, fatigue and irregular heartbeats. When combined with high bicarbonate levels, the risk of severe cardiac events increases dramatically.
“[Health care] providers should enforce strict safety protocols including continuous lab testing and individualized treatment modifications when dialyzing with GranuFlo and NaturaLyte,” McKinney said.
Heart Attacks
GranuFlo and NaturaLyte, commonly used in dialysis treatment, have been associated with a higher risk of heart attacks. In 2011, a study conducted by their manufacturer found that improper use of GranuFlo could increase the likelihood of heart attacks in dialysis patients.
The problem relates to the sodium diacetate additive in GranuFlo, which the body converts to bicarbonate. Some bicarbonate is crucial for balancing the body’s acidity during dialysis. However, incorrectly mixed GranuFlo solutions can elevate bicarbonate in the blood to dangerous levels, thereby increasing the risk of heart attacks.
Case Study: Sudden Cardiac Arrest During Dialysis
In November 2011, Stephanie Boone from Texas was being treated for her serious kidney condition. She was receiving dialysis, a treatment that helps filter waste from the blood when the kidneys can’t do it on their own. Boone got therapy at the Fresenius Medical Care Southeast Kidney Center. While there, she received either GranFlo or NaturaLyte, both solutions used during dialysis.
Dangerous Side Effects
During her dialysis treatment, Boone suffered cardiac arrest. Medical personnel immediately transported her to a nearby hospital. According to court documents, she claimed the cardiac arrest was directly linked to the dangerous effects of GranFlo or NaturaLyte.
GranuFlo contains acetic acid and sodium diacetate, which the liver converts into bicarbonate. This process can dangerously increase bicarbonate levels beyond those prescribed by a physician.
As a result, patients like Boone can receive approximately four mEq/L (milliequivalent per liter) more bicarbonate than intended. Elevated bicarbonate levels can lead to metabolic alkalosis. With this condition, the blood becomes too alkaline, increasing the risk of severe complications such as heart attacks.
Impact and Consequences
Stephanie Boone’s cardiac arrest caused significant medical and emotional distress. She endured severe physical trauma and faced potential long-term health impacts as a result of the defective dialysate solutions.
Cardiopulmonary Arrest
Cardiopulmonary (CP) arrest is another severe side effect linked to GranuFlo and NaturaLyte. With this condition, the heart and lungs suddenly stop functioning.
In November 2011, Fresenius issued an internal memo. This memo warned that having high levels of bicarbonate in the blood can significantly increase the risk of cardiac arrest in people undergoing dialysis. The data showed that patients with high bicarbonate levels before the dialysis faced a six to eight times greater risk of CP arrest and sudden cardiac death.
The memo recommended closely monitoring patients with high bicarbonate levels, defined as 24 mEq/L or higher, and adjusting treatment to keep the levels within a safer range. Doctors should regularly check and adjust bicarbonate levels in these patients.
Stroke Risk
Strokes are a serious risk associated with the use of GranuFlo and NaturaLyte. A stroke happens when the blood supply to part of the brain is interrupted or reduced. This prevents brain tissue from receiving oxygen and nutrients, which can lead to brain damage or death.
GranuFlo and NaturaLyte may cause elevated bicarbonate levels. This can lead to a chemical imbalance in the blood, increasing the risk of strokes. Metabolic alkalosis, for example, can exacerbate pre-existing conditions that may lead to stroke.
Additionally, low potassium levels can increase the risk of stroke, according to the American Heart Association.
In 2016, then-Kentucky Attorney General Andy Beshear filed a lawsuit. In it, he claimed that GranuFlo caused strokes and other complications among the commonwealth’s Medicaid patients. He claimed Fresenius knew about these risks but failed to inform non-Fresenius clinics. This led some patients to develop dangerously high bicarbonate levels and metabolic alkalosis.
Other Side Effects of GranuFlo and NaturaLyte
Besides heart attacks, cardiopulmonary arrest, strokes, alkalosis and hypokalemia, GranuFlo and NaturaLyte are associated with several other side effects.
- Cardiac arrhythmia
- This irregular heartbeat can cause sudden cardiac arrest.
- Electrolyte imbalance
- Besides low potassium levels (hypokalemia), the solutions may cause high carbon dioxide levels (hypercapnia). This can lead to several health issues.
- Low blood pressure (hypotension)
- An imbalance in blood chemistry can result in hypotension, which can cause dizziness, fainting and other complications.
- Low oxygen levels (hypoxemia)
- Reduced oxygen in the blood can cause serious complications, including organ damage.
- Renal failure
- Although used to manage kidney failure, improper use of these products can exacerbate kidney problems.
If you or a loved one has suffered from side effects related to GranuFlo or NaturaLyte, it is essential to seek medical advice. Thousands of people injured by the solutions filed GranuFlo and NaturaLyte lawsuits.
Editor Lindsay Donaldson contributed to this article.
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