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The Granuflo Drug Lawsuit

Introduced by Fresenius Medical Care North America (FMCNA) in 2003, Granuflo is a kidney dialysis or hemodialysis additive comprised of a dry acid product containing sodium diacetatein. Since the release of Granuflo, there have been reports that the additive can steadily increase a patient’s serum pre-dialysis bicarbonate levels, and if not regulated and adjusted, can lead to cardiac issues and a host of other health complications.

What is Granuflo?

Granuflo is a dialysate, which is a dry acid product containing sodium diacetate. It is prescribed to patients who are undergoing hemodialysis to treat acute and chronic renal failure. Granuflo works in conjunction with the hemodialysis machine and dialyzer to eliminate wastes from the blood. Granuflo as a dialysate is regulated as a medical device by the Federal Drug Administration. The FDA initiates health warnings and receives complaints for medical devices as well as medications.

Granuflo Usage and Statistics

Granuflo is manufactured by Fresenius Medical Care, which is the largest provider of dialysis services and products in the world. Although Granuflo has helped thousands of patients, some claimants argue that some dialysis products provided by Fresenius Medical Care may have come with insufficient warnings and instructions for their safe use. Specifically, doctors did not received sufficient information about the prescribing the medication and adjusting prescription amounts based on each individual’s bicarbonate levels prior to dialysis. For example, reports indicate that if a patient had elevated pre-dialysis bicarbonate levels they may have faced a significantly greater risk of cardiopulmonary arrest and sudden cardiac death in the dialysis clinic. Claimants argue it is the failure of Fresenius Medical Care, who did not provide sufficient warnings about the Granuflo’s proper use, which has led to the increased number of patients who have suffered cardiac events, including heart attack, cardiopulmonary arrest, and sudden cardiac death.

How Granuflo Works

Granuflo is an acid concentrate which contains certain chemicals that can be converted in a patient’s body to form bicarbonate. Research indicates that sodium bicarbonate can dramatically slow the progress of chronic kidney disease. In fact, bicarbonate for some patients can delay the need for dialysis, and in other cases, medical doctors believe it could help certain individuals, who are already on dialysis, reverse their condition. For people with healthy kidneys, however, the kidneys are able to produce sufficient bicarbonate. In fact, it’s estimated that a healthy person’s kidneys can produce up to two hundred and fifty grams of bicarbonate per day to neutralize acidity in the body and restore the body’s pH balance. If the kidneys are unhealthy, however, excess acid builds up in the body, leading to acidosis.

Side Effects of Granuflo

  • Unfortunately, Granuflo has been linked to a number of serious side-effects for certain users. The most serious side-effects include:
  • Metabolic Alkalosis
  • Hypotension (Low blood pressure)
  • Heart Attack
  • Cardiac Arrest
  • Stroke
  • Heart Arrhythmia
  • Low potassium levels in the blood
  • Hypoxemia

Granuflo Medical Studies

Granuflo is currently used throughout the United States in thousands of kidney dialysis centers. In fact, it’s estimated up to one-third of all dialysis patients use this additive. After Fresenius Medical Care (FMC) was notified of the potential dangers of Granuflo (i.e., higher-than-expected rates of cardiopulmonary arrest in its clinics), they conducted their own study from January 1, 2010, through December 31, 2010. In the Fresenius Medical Care (FMC) study more than 941 patients who had suffered cardiopulmonary arrest in 667 FMC facilities were reviewed. The conclusion drawn from the study was that their medical complications could be attributed to the improper mixing of Granuflo and bicarbonate prescriptions. At the completion of this study Fresenius Medical Care (FMC) notified their doctors via an internal memo. This memo was sent on November 4, 2011. Unfortunately, this information was not disseminated to other doctors, the FDA, or the public. These groups were not notified until months later when the Federal Drug Administration (FDA) received a report.

Granuflo Black Box Warnings

  • In June 2012, the FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. According to the Federal Drug Administration, these products have been shown to increase the level of high serum bicarbonate in certain patients which use them for kidney dialysis. Patients who experience high levels of serum bicarbonate may experience metabolic alkalosis, which can lead to a host of other very serious heath complications, including hypoxemia, hypercapnia, and low blood pressure. A number of patients have also suffered cardiopulmonary arrest. Among the concerns received by the FDA were complaints regarding “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” If errors occurred the FDA claims this could lead to metabolic alkalosis and the side-effects listed above. Not only are healthcare professionals encouraged to notify the FDA if there are negative side-effects from taking this medication, they are also supposed to “review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient’s overall bicarbonate levels.” The New York Times also reports that Fresenius notified medical directors and their own doctors that GranuFlo “appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest” as early as November 2011, but the company failed to notify the FDA or the public of their concerns until March 2012.
  • 06/27/2012 - Recall Notice3 - FDA
  • 05/25/2012 - Safety Communication4 - FDA