GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate are manufactured by Fresenius Medical Care North America. Both products are administered to kidney dialysis patients to replace amino acids lost during dialysis. However, the U.S. Food and Drug Administration (FDA) has recalled both products, saying their use may cause serious adverse health consequences or death.

The FDA’s action against GranuFlo and NaturaLyte is a Class I recall. This is the most serious type of recall and one that involves situations in which the FDA believes there is a reasonable probability that use of the products will cause serious adverse health consequences or death.

The threat of GranuFlo / NaturaLyte side effects is secondary to their primary problem, which is that they can contribute to elevated bicarbonate levels in dialysis patients if administered at improper dosages. Elevated bicarbonate levels can, in turn, lead to metabolic alkalosis – a potentially deadly pH imbalance in the blood.

GranuFlo, NaturaLyte and Metabolic Alkalosis

Alkalosis is a condition in which the body fluids have excess base (alkali). The opposite condition is excess acid (acidosis). The kidneys and lungs function to maintain the proper balance of acids and bases in the body.

Metabolic alkalosis is caused by too much bicarbonate, a base, in the blood.

The FDA, in its Class I recall notice for GranuFlo and NaturaLyte, says metabolic alkalosis is a significant risk factor associated with:

• Heart attack (cardiopulmonary arrest) – A heart attack occurs when blood flow to a part of the heart is blocked or otherwise insufficient for a long enough period that part of the heart muscle is damaged or dies. A heart attack can cause instant death or long-term injury and debilitation. Low blood pressure, an additional side effect of metabolic alkalosis, can also contribute to cardiopulmonary arrest.
• Low blood pressure (hypotension) – Hypotension occurs when blood pressure during and after each heartbeat is much lower than usual. This means the heart, lungs, brain and other parts of the body do not get enough blood.
• Irregular heart rate (cardiac arrhythmia) – An arrhythmia is a disorder of the heart rate (pulse) or heart rhythm such as beating too fast (tachycardia), too slow (bradycardia) or irregularly. Some arrhythmias may be life threatening if not treated right away or if you do not respond well to treatment. An irregular heart rate can cause heart failure.
• Low blood oxygen (hypoxemia) – In most cases, hypoxemia causes no more than shortness of breath. But in severe or prolonged cases of low blood oxygen, it can cause cough, headache, insomnia, fluid retention and, if not treated, potentially fatal pulmonary edema (excess fluid in the lungs).
• Increased blood carbon dioxide (hypercapnia) – Carbon dioxide is cleansed from the blood by the lungs, where it is exhaled as oxygen is inhaled. Hypercapnia and hypoxemia go hand in hand. Severe hypercapnia may lead to respiratory failure and possibly death.
• Low blood potassium (hypokalemia) – Potassium is necessary for the body’s cells, especially nerve and muscle cells, to function properly. Severe hypokalemia can cause abnormal heart rhythms, paralysis (which can include the lungs), muscle damage, fatigue and constipation.

Metabolic alkalosis that is left untreated can lead to convulsions, coma and heart failure.

Contact a GranuFlo / NaturaLyte Injury Lawyer Today

If you or a loved one has used GranuFlo or NaturaLyte and suffered heart attack, convulsions, heart failure, heart arrhythmia, coma, death or other complications, you should act now to protect your rights.

Learn more about your legal options from an experienced GranuFlo / NaturaLyte injury lawyer today. Call The Driscoll Firm, LLC, at our toll-free number or submit our online contact form. We have a record of taking on major medical product companies and standing up for the rights of injured patients and their families. We can get started on your case right away.

For more information:

• Medical Device Recalls – Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, U.S. Food and Drug Administration
• FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis, U.S. Food and Drug Administration
• NaturaLyte Liquid and Granuflo Acid Concentrate Bicarbonate Alkalosis, Fresenius Medical Care North America
• Low Back Pain – Acute, A.D.A.M. Medical Encyclopedia, PubMed Health
• MayoClinic.com