GranuFlo is described by its manufacturer, Fresenius Medical Care, as “the most-widely prescribed dry acid product in the dialysis industry today.” Fresenius states that GranuFlo is the “safest dry acid product” for both patients and staff because it eliminates the need for hazardous liquid glacial Acetic Acid.
Unfortunately, the hundreds of people who suffered sudden cardiac events after using GranuFlo would likely not agree that the product is safe. In fact, GranuFlo presents such a high risk to patients that, in March 2012, the FDA provided notice that a Class I recall had been initiated. The reason for the recall was to warn patients of significant dangers associated with a high concentration of acetate or sodium diacetate contained within GranuFlo and the related product NaturaLyte.
This warning came too late for many patients who experienced complications from GranuFlo. If you or a loved one was injured as a result of this product, you could be entitled to compensation. The dangerous drug lawyers at Roberts & Roberts are currently reviewing claims from patients who have suffered adverse events related to the use of GranuFlo.
In the United States, approximately 400,000 patients have conditions that make it impossible for their kidneys to properly filter waste.These patients must undergo dialysis, which can cause a buildup of acid in the bloodstream.
To neutralize acid buildup, an alkaline substance must be administered to patients. When patients undergo dialysis, the alkaline substance is part of a special solution called dialysate, which is added to a dialysis machine.The dialysate contains water and chemicals.Three-stream dialysis machines need to contain appropriate amounts of all chemicals, including alkaline substances.
GranuFlo is an alkaline product administered to thousands of dialysis patients. Fresenius both runs its own dialysis centers and provides GranuFlo to other centers throughout the U.S. In total, Fresenius is the provider of dialysis products for around a third of all dialysis patients in the United States.The company operates approximately 1,800 U.S. dialysis clinics serving 138,000 patients in addition to those treated with Fresenius products at other centers nationwide.
GranuFlo can convert to bicarbonates in the body. An overdose of bicarbonates can cause cardiac problems, including catastrophic injuries to the heart and cardiovascular death.
When the product was released, healthcare providers were unaware of the makeup of GranuFlo that prompted conversion to bicarbonates. Providers did not account for this in mixing the medication, and many patients began to suffer cardiac arrest and other heart problems in dialysis clinics.
By November 2011, more than 900 people had suffered a sudden cardiac event at clinics operated by Fresenius. Evidence indicates that Fresenius knew of the problems as far back as 2003 when the FDA originally approved GranuFlo and another dialysis solution, NaturaLyte. However, Fresenius said nothing about the risks at the time of the product launch.
Dangers of GranuFlo
When patients have an overdose of bicarbonates in their body, this can cause metabolic alkalosis, or elevated pH levels.
Symptoms of metabolic alkalosis include:
- Twitching or spasms in the muscles
For those experiencing metabolic alkalosis, it is important to seek medical treatment immediately as elevated levels of bicarbonates can be deadly.
Complications associated with metabolic alkalosis include:
- Low blood pressure
- Hypoxemia (low levels of oxygen in the blood)
- Hypokalemia (low levels of potassium in the blood)
- Irregular heart beat (cardiac arrhythmia)
- Cardiac arrest
- Hypercapnia (excess levels of carbon dioxide in the blood)
The increased risk of developing metabolic alkalosis from GranuFlo was confirmed in a Nov. 4, 2011, memo from Fresenius, which informed doctors in its own clinics that 941 patients had suffered a cardiac arrest in 2010. Fresenius provided guidelines to physicians at its clinics and warned that the risk of a heart attack was six to eight times greater during dialysis if the wrong dose was administered.
Unfortunately, while it alerted its own clinics, it failed to send out notice to the thousands of other physicians, clinics and care providers administering GranuFlo to patients.Approximately 125,000 patients being treated at clinics not run by Fresenius were receiving GranuFlo, and their physicians were not informed that improperly mixing the drug could cause cardiac arrest.
A presentation at the American Society of Nephrology in November 2011 also identified the dangers, based on evidence from a study of 16,899 patients.
Prompted by growing evidence of problems and complications, the FDA asked Fresenius about potential side effects of alkalosis. Fresenius sent out an urgent product notification to outside clinics.Just two days after this notice, the FDA issued a Class I recall in March 2012.
The recall was intended to ensure that all physicians and patients were made aware of the grave dangers of GranuFlo. According to the FDA, “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Legal Help for Victims of GranuFlo Side Effects
Victims who fell ill or family members of patients who died while using GranuFlo could be entitled to bring a civil lawsuit to obtain damages, including payment of medical costs, lost wages, pain and suffering, emotional distress and wrongful death damages. Multi-district or class-action litigation could also provide a way for injured victims to take action against Fresenius, depending upon the individual circumstances.
To learn more about options for obtaining compensation,contact a GranuFlo injury attorney at Roberts & Roberts today for a free confidential claim evaluation.Call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.
- New York Times – “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry”