The Dangers Of Granuflo
GranuFlo is a substance frequently used in kidney dialysis procedures, counteracting the harmful effects of acids and others substances in the bloodstreams of dialysis patients. GranuFlo works by converting into bicarbonates when in the patient’s body, effectively cancelling out excess acid compounds. However, this neutralizing ingredient is present in such significant quantities in GranuFlo that it may place some patients at risk of suffering a serious illness or medical emergency.
According to some studies, GranuFlo is linked to an increased risk of several medical issues which can seriously threaten the lives and health of those who use this product. Some of the most commonly reported of these potential health problems includes the following:
- Low blood pressure
- Cardiac arrhythmia
- Heart attack
- Metabolic alkalosis
- Sudden death
All of these medical problems have been linked to the use of GranuFlo, and in some cases, patients are more than six times as likely to experience these types of issues as patients on other hemodialysis products.
FDA Investigation and Recall
In 2010, an unusually high number of deaths caused by cardiac arrest occurred in clinics owned and operated by the manufacturers of GranuFlo, Fresenius Medical Care. In response, Fresenius conducted their own internal investigation of potential problems that might be leading to the increase in deaths, and concluded that excess bicarbonate levels in the patients’ bloodstreams were likely the source of the problem. As a result, the company issued a memo to its staff warning them of the potential problem and advising against providing GranuFlo products to patients whose bicarbonate levels were too high pre-dialysis.
This memo was not, unfortunately, provided to the general public, government regulators, or even non-Fresenius owned clinics which used GranuFlo. Therefore, Fresenius allowed hundreds of thousands of patients to be exposed to a potentially life-threatening substance solely in order to avoid this potentially damaging information from coming to light.
Fortunately, an anonymous internal source forwarded the memo to the FDA in early 2012, eventually resulting in the company issuing a Class 1 recall of GranuFlo from all locations in which the product was used. Class 1 recalls are the most serious type of recall under the FDA’s guidelines, meaning that the product being recalled is considered life-threatening to those who use it.
Know Your Legal Rights!
Patients who were administered GranuFlo before the recall was issued may have experienced serious side effects as a result of their medical treatment. The consequences of these effects can be far-reaching, and often includes significant financial duress as a result of costly medical treatment sought to treat GranuFlo side effects and income lost from time spent away from work.
In these circumstances, patients may have the right to pursue a GranuFlo lawsuit to help recover some of the damages that they may have suffered as a result of Fresenius Medical Care’s negligence in failing to provide patients and staff with the necessary information about potential risks associated with their products. Taking legal action can help to restore the patient’s losses caused by their medication.