GranuFlo and Death - Consumer Justice Foundation

GranuFlo and Death

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FMC Failed to Warn Consumers about Fatal Side Effect Risk

FMC operates about one-third of all dialysis clinics in the United States and is the leading supplier of dialysis products and medications like GranuFlo for clinics operated by other dialysis providers in the U.S. and Europe. In November 2011, FMC became aware of information that suggested that GranuFlo may be linked to cardiac arrest and other life-threatening side effects, and the company issued an internal memo warning FMC-run dialysis clinics alone about this risk. According to the memo, as many as 941 GranuFlo patients had suffered sudden cardiac arrest due to the improper administration of the dialysis drug. Unfortunately, FMC failed to warn clinics operated by other dialysis providers about the risk of fatal side effects associated with GranuFlo, possibly putting more than 100,000 patients at non-FMC dialysis clinics at unnecessary risk of major heart side effects and death. According to some sources, potentially fatal cardiac events may be four to six times as common in patients taking GranuFlo, compared to other dialysis patients.

FMC Under Investigation for GranuFlo Heart Side Effects

Dialysis is a process during which toxic waste is removed from the body in patients whose kidneys aren’t able to do so properly. Dialysis patients are often administered bicarbonates, because they neutralize the build-up of acid that occurs in the blood during the dialysis process. Fresenius Medical Care has marketed GranuFlo as a superior dialysis drug, claiming that the medication allows for greater conversion of bicarbonates. Unfortunately, GranuFlo has been shown to cause elevated bicarbonate levels in kidney failure patients, which can lead to a condition called hemodialysis metabolic alkalosis, a major risk factor for the following side effects:

  • Cardiac arrest
  • Stroke
  • Heart attack
  • Low blood pressure
  • Hemodialysis cardiac arrest
  • Hemodialysis cardiopulmonary arrest
  • Arrhythmia
  • Altered mental status (confusion)
  • Death

Contact a GranuFlo Attorney Today

Although FMC became aware of potential GranuFlo side effects in November 2011, it wasn’t until March 2012, after the FDA received a copy of FMC’s internal memo from an anonymous source, that patients and healthcare providers were warned about the risk of GranuFlo heart side effects and death. If you have suffered from an alleged GranuFlo side effect, or if you lost a loved one to a fatal complication that you believe to be linked to the dialysis drug, contact a qualified GranuFlo attorney to discuss your legal options. The medical bills associated with the immediate treatment and long-term medical care required by victims of potential GranuFlo side effects can be costly, as can the funeral and burial costs related to fatal complications. With the help of a knowledgeable GranuFlo lawyer, you may be able to file a GranuFlo lawsuit against FMC in order to pursue financial compensation for your injuries, medical bills, pain and suffering, loss of quality of life, and more.

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