Granuflo – Deemed Unsafe by the FDA

granuflo drug unsafeGranuFlo, a medication used in conjunction with NaturaLyte during dialysis, has been deemed unsafe by the Food and Drug Administration (FDA) as of March 2012. In March, the FDA issued a Class I recall on this medication and listed it as a dangerous drug. This was a direct result of a whistleblower who notified the FDA of the dangers associated with the drug.


GranuFlo is manufactured by Fresenius Medical Care (FMC), a German based medical company that is the largest producer of dialysis equipment, supplies and medicines in the world. In 2010, FMC accounted for nearly one-third of all dialysis clinics in the United States, and their products were used by other dialysis clinics in the U.S. as well.

While FMC stated that the GranuFlo medication was easy to mix to the right concentration with NaturaLyte for dialysis, the simple truth was that mixing to the correct strength was difficult, and patients were having adverse reactions. Additionally, dialysis administrators were not notified about the correct levels of bicarbonate to prescribe to a patient in-between dialysis visits. This caused many patients to have very high levels of bicarbonate in their system, and cardiac arrest was often the result.

Patients suffering from adverse effects of this medication were subjected to the following side effects:

  • Cardiac Arrest
  • Sudden Heart Attacks
  • Hemodialysis Cardiac Arrest
  • Hemodialysis Pulmonary Arrest
  • Arrhythmia
  • Altered Mental State or Confusion
  • Low Blood Pressure
  • Stroke
  • Death

Many of these side effects were reported during dialysis, including 900 deaths from cardiac arrest in 2010.

FMC became aware of this problem and notified their clinics to stop using the product in November of 2011. However, the company failed to notify clinics outside of their brand name or patients that were currently receiving treatment, or had in the past. This failure to notify kept the product on the market and people remained in danger.

A whistleblower notified the FDA of the problem, and the medications were subsequently pulled from the market. In the meantime, many people have unknowingly suffered from the effects of this medication, and many have died.

What To Do If This Has Happened To You

If you have suffered from the adverse side effects of this dangerous medication, you should request your case be evaluated by a dangerous medicine attorney. An attorney can determine what types of compensation you are entitled to for the damages. If you have lost a loved one due to this medication, your dangerous medication attorney will explain any additional rights you may have to make a claim against this medical manufacturer.

Related Information: NaturalyteLawsuits

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