GranuFlo and NaturaLyte

Fresenius Dialysis

Fresenius dialysis is a dialysis service provided by Fresenius Medical Care, a German medical device company. There are numerous Fresenius dialysis locations around the country that are available for patients to receive treatment. Fresenius dialysis is also available in other parts around the world. Fresenius dialysis replaces the lost function of the kidneys for patients with chronic or acute renal failure.

Patients with kidney problems often require dialysis treatment as an absolute necessity since the kidneys provide an essential life function. Fresenius dialysis is a four-hour process that involves removing a patient’s blood and filtering waste products and other harmful substances before pumping the blood back into the patient. Dialysis is typically required three times a week to allow for steady bodily function.

Fresenius Dialysis Centers

Fresenius dialysis administers the majority of the country’s dialysis treatments for patients. There are more than 1,800 Fresenius dialysis centers in the U.S. The popularity of Fresenius dialysis Centers also makes substantial usage of GranuFlo and NaturaLyte which are medications used to clean the blood of dialysis patients.

Fresenius dialysis has faced some problems during the course of its operation. Several patients have encountered serious health problems as a result of their services. Some patients have also died from drugs that were administered and from failure to follow protocol.

One of the most notable scandals involving Fresenius dialysis is the report of an internal memo that was concealed from the public. The internal memo reported potentially lethal risks, such as heart attack, from some of their products. These issues have all contributed to lawsuits that were filed against Fresenius dialysis.

GranuFlo is a powdered drug that treats acute renal failure and chronic kidney disease. It is used as a chemical component of dialysis treatment for these conditions. GranuFlo received approval from the U.S. Food and Drug Administration (FDA) in 2003. Its manufacturer, Fresenius Medical Care (FMC), dominates the dialysis market in the United States. In 2011, FMC netted $12.8 billion in revenue from its disposable products and dialysis machines.

Roughly 400,000 Americans who suffer kidney disease undergo dialysis treatment to filter their blood several times each week. Of these 400,000, it is estimated that nearly half use GranuFlo or its liquid counterpart NaturaLyte. A number of these GranuFlo treatments are administered in FMC clinics. However, patients who are given incorrect dosages are six to eight times more likely to suffer cardiac arrest. FMC now faces mounting lawsuits for death and injury resulting from the use of GranuFlo and NaturaLyte.

GranuFlo Heart Attack

GranuFlo is an acid concentrate made for use in dialysis treatment. Dialysis treatment helps filter the blood of patients who suffer kidney failure or disease. GranuFlo is manufactured by Fresenius Medical Care (FMC), the largest worldwide manufacturer of kidney dialysis products and services. FMC owns and operates roughly 1,800 clinics which administer GranuFlo and its sister drug NaturaLyte in dialysis treatment.

Since the release of GranuFlo, a number of adverse events were reported from users and clinics administering dialysis treatment using the drug. Since the increased heart attack risk was discovered, a number of lawsuits have been filed against FMC by injured patients and family members who lost a loved one from a GranuFlo heart attack and other adverse effects.

What Is a Heart Attack?

A heart attack, or myocardial infarction, occurs when a coronary artery suddenly becomes blocked. Coronary arteries supply blood to the heart. During a heart attack, this artery blockage prevents the heart muscle from receiving adequate blood supply. This leads to a condition called ischemia, or blood supply restriction. As a result, the heart cells within the muscle become damaged. In severe cases, death of the heart cells can occur.

GranuFlo Heart Attack Symptoms

Patients experiencing symptoms of a GranuFlo heart attack should seek immediate emergency medical attention by calling 911. If a patient suffering a heart attack fails to receive immediate treatment, death can occur. In many cases, symptoms of a heart attack can be tell-tale. However, some patients experience “silent” heart attacks, which do not exhibit symptoms.

GranuFlo heart attack symptoms include:

  • Extreme weakness or shortness of breath
  • Nausea or vomiting
  • Sudden dizziness and light-headedness
  • Arrhythmia, or irregular heartbeat
  • Tachycardia, or increased heart rate
  • Pressure, heaviness, pain, or discomfort in the arm, chest, or below the breastbone
  • Discomfort which radiates to the jaw, throat, back, or arm
  • Sensation of indigestion, choking, or fullness similar to heartburn

GranuFlo Heart Attack Causes

The main cause of a GranuFlo heart attack is from incorrect dosing when administering GranuFlo. Patients with kidney failure or disease have a decreased ability to naturally filter the acid buildup that occurs in the blood. During dialysis treatment, the patient’s blood is filtered and the acid levels are neutralized using an artificial kidney. Dialysis treatment removes, filters, and returns the blood to the patient’s body. An alkaline substance called bicarbonate aids this neutralization process. GranuFlo and Naturalyte contain bicarbonate for this reason. However, many medical professionals were unaware that natural ingredients in GranuFlo and NaturaLyte are converted into excess bicarbonate.

Unexpectedly high bicarbonate levels can cause a condition called metabolic alkalosis. Metabolic alkalosis can lead to a GranuFlo heart attack if left untreated. The condition occurs when the patient’s blood has excessive levels of base, or alkali. This is indicated by a blood pH that is elevated beyond the normal range.

In severe cases, metabolic alkalosis can cause heart attack, stroke, and cardiac arrest in patients. If left untreated, these conditions can cause patient death. A main warning sign of metabolic alkalosis and potential GranuFlo heart attack can be seen when a patient experiences arrhythmia, or irregular heartbeat.

FMC Internal Memo

In 2011, FMC issued an internal company memo discussing GranuFlo heart attacks and other severe cardiac side effects that resulted from GranuFlo and NaturaLyte use. The memo stated that more than 941 GranuFlo and NaturaLyte patients suffered cardiac arrest in FMC clinics.

However, FMC failed to notify the FDA and third-party dialysis clinics which administered GranuFlo and NaturaLyte. The memo was anonymously leaked to the FDA in 2012. The findings of increased GranuFlo heart attack and cardiac arrest risks led the FDA to issue a Class I recall of GranuFlo and NaturaLyte. Additionally, the FDA is investigating FMC for withholding this crucial information from the public.

What Is Dialysis?

During dialysis treatment, a patient’s blood is removed, filtered of harmful substances, then returned to the body. The kidney is typically responsible for this filtration process. However, kidney disease and renal failure render the kidneys incapable of performing this essential function.

During the dialysis process, a solution called dialysate is used to clean the patient’s blood. Bicarbonate is an important substance in the dialysate solution. GranuFlo contains acetate and sodium diacetate, which produce bicarbonate. Many dialysis machines today are three-stream. This means that they mix dialysate using bicarbonate, filtered water, and acid concentrate.

When the process is complete, the filtered blood is returned to the body, along with additional bicarbonate. It is important that the dialysis machines are properly calibrated in order to account for the bicarbonate already present in the GranuFlo dialysate solution.

Side Effects of GranuFlo

The main side effect of GranuFlo and NaturaLyte is an excess of bicarbonate in the bloodstream. This bicarbonate surplus can lead to potentially deadly conditions, including metabolic alkalosis. Metabolic alkalosis occurs when the body’s pH level is elevated beyond a normal level. In some cases, these heightened bicarbonate levels can lead to death.

Excess bicarbonate from GranuFlo can also cause:

  • Low blood pressure
  • Cardiac arrest
  • Cardiac arrhythmia, or irregular heartbeat
  • Hypoxemia, or lowered blood oxygen
  • Hypokalemia, or lowered blood potassium
  • Hypercapnia, or increased blood carbon dioxide

GranuFlo Recall

In November 2001, FMC’s North American office sent out an internal memo to doctors who used GranuFlo and NaturaLyte in FMC’s dialysis clinics. This memo notified doctors that in 2010, 941 patients suffered cardiac arrest from GranuFlo and NaturaLyte use. Additionally, the memo outlined specific guidelines for physicians when administering GranuFlo and NaturaLyte. Unfortunately, FMC did not send this memo to non-FMC clinics.

In March 2012, the FDA sent an inquiry to FMC regarding the side effects of alkalosis. Shortly afterward, an Urgent Product Notification was sent to non-FMC clinics. The FDA then issues a Class I recall for GranuFlo and NaturaLyte products that were manufactured from January 2008 and June 2012 that were used in three-stream dialysis machines.

A Class I recall is the most serious FDA recall. It alerts the public of adverse health reactions and possible death. The recall did not require that GranuFlo and NaturaLyte were removed from clinics. Instead, it required that proper dosing procedures and label updates were implemented. The recall also warned doctors of inaccurate dosage dangers.

GranuFlo Lawsuits

A number of GranuFlo and NaturaLyte lawsuits have been filed. Many of these cases involve the death of a loved one from using these dialysis products. Plaintiffs claim that consumers were not adequately warned of the dangers of using GranuFlo and NaturaLyte. It is recommended that victims of these FMC dialysis products immediately seek a qualified and experienced attorney. An attorney can help discuss legal options and file a claim.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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