By Sarah Mirando  |  December 12, 2012

Category: Pharmaceuticals
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Why Is GranuFlo & NaturaLyte More Dangerous Than Other Dialysis Drugs?

By Andrea Gressman

 

GranuFlo recall lawsuitIf you receive kidney dialysis, the Class I recall of GranuFlo and NaturaLyte in June of 2012 was probably some pretty alarming news, even if you don’t use those particular dialysis products. You may have thought about whether your dialysis treatment medication would have the same side effect or not. However, it is important to realize that the side effect issues associated with GranuFlo and NaturaLyte are not necessarily shared with any of the other dialysis treatment options.

NaturaLyte and GranuFlo are both concentrates that are used in kidney dialysis treatment. Their manufacturer is Fresenius Medical Care, which happens to be based out of Germany. However, they do own and operate a number of kidney dialysis centers in the United States in addition to manufacturing these popular dialysis treatment products.

In a memo issued by Fresenius in November of 2011, they revealed the main issue with GranuFlo and NaturaLyte side effects. They explained that the dangerous side effect risk came from the two concentrates causing metabolic alkalosis. This is a potentially deadly side effect that has led many GranuFlo and NaturaLyte patients to experience heart attacks and other serious side effects. Sadly, the internal memo — which was only issued to Fresenius-owned dialysis centers and not all centers that used GranuFlo and NaturaLyte — claimed that there had been over 900 deaths due to side effects of GranuFlo and NaturaLyte.

So, the common question seems to be what makes these two dialysis medications so much more dangerous than other kidney failure treatment options? The answer is surprisingly simple. The sole purpose of a patient going through dialysis is so that the toxins are cleaned from the blood stream of the patient when the patient’s kidneys are no longer functioning correctly. So, when dialysis occurs there can be an acid that builds up in the patient’s blood. This can then cause the pH to be imbalanced. That is where products like GranuFlo and NaturaLyte come in. They are used to keep the acid levels and a healthy level.

This is where the problem comes in. Other dialysis concentrates are made up of acetic acid. However, GranuFlo and NaturaLyte are made up of sodium diacetate. As a result, this gives the two products two-times as much acetate as other dialysis treatment products. What this means is that NaturaLyte and GranuFlo can potentially raise the bicarbonate levels of the kidney dialysis patient a great deal more than other dialysis products. Sadly, Fresenius did not do a good job of educating doctors of this information prior to releasing GranuFlo and NaturaLyte onto the market and as a result the doctors were mixing the concentrate at the same dose as they would with other dialysis products. Essentially this caused them to overdose their patients and as a result many patients have experience severe side effects that have resulted in death.

Some of the less severe side effects that GranuFlo and NaturaLyte caused their patients to experience included the following:

* Nausea
* Headaches
* Cramps
* Diarrhea

Some of the more severe side effects caused by GranuFlo and NaturaLyte include:

* Hyperventilation
* Seizures
* Convulsions
* A drop in blood pressure
* Arrhythmias
* Cardiac arrest. (heart attack)

After the internal memo was released by Fresenius it was then leaked to the FDA. The FDA then began their investigation in the spring of 2012 and then subsequently issued a Class I recall in June of 2012. However, there are still many GranuFlo and NaturaLyte victims out there that have not associated the side effects that they experienced with the dialysis products they used. As more awareness is brought forward regarding the serious GranuFlo and NaturaLyte side effects, more and more GranuFlo and NaturaLyte lawsuits will likely be filed.

If you are a GranuFlo/NaturaLyte heart attack victim, go to the Kidney Dialysis, GranuFlo & NaturaLyte Class Action Lawsuit Settlement Investigation page to submit your information. You will receive a free legal review of your potential GranuFlo/NaturaLyte lawsuit. Dialysis injury lawyers are standing by to review your situation.

 

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Updated December 12th, 2012

 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

 

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