Sarah Mirando  |  April 16, 2013

Category: Pharmaceuticals

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Kidney Dialysis Products Linked to Heart Attack, Stroke & Death

By Robert J. Boumis

 

Hemodialysis treatmentPeople with serious kidney disease have to trust their dialysis supplies. These medical tools allow people to survive with critical damage to their kidneys. But several common dialysis products may have betrayed that trust. Last year, the FDA recalled two common dialysis products after their use was linked to an increased risk of cardiac arrest and sudden cardiac death associated with their use.

GranuFlo, NaturaLyte and Alkalosis

About 400,000 Americans rely on dialysis to sustain them through end-stage renal disease, or ESRD. More than one out of three of these patients use GranuFlo and NaturaLyte products, manufactured by Fresenius Medical Care. They are widely used because they are more concentrated than other dialysis products. This translates to saved storage space at dialysis centers.

However, under certain conditions these products produce a condition called Alkalosis. In Alkalosis, the hydrogen ion concentration in the blood drops, lowering blood pH. This decrease in pH interferes with other ions within the body, including the ions that muscle tissue needs to function properly. This imbalance can lead to disturbed muscle function, which can also affect the cardiac muscles when the ion concentrations in heart tissue are altered.

Internal Memo and FDA Recall

In 2011, Fresenius put out an internal memo to its doctors. This memo explained that GranuFlo and NaturaLyte can cause alkalosis if dosed incorrectly. The memo stated that over 900 patients in a Fresenius dialysis facility suffered cardiac arrest in 2010. However, other dialysis clinics did not find out about the problem until the FDA issued a recall the next year.

In March of 2012, the FDA issued a recall for both NaturaLyte and GranuFlo. This was prompted by the realization that dialysis patients using these products were up to six times more likely to suffer cardiac arrest and sudden cardiac death. The recall was the highest class of recall issued by the FDA, a Class I recall. This class of recall is only issued for products that pose an immediate risk of life-threatening health problems.

Lawsuits Allege Fresenius Failed to Warn Patients

Fresenius Medical Care has been hit with dozens of lawsuits by victims of GranuFlo and NaturaLyte side effects and their families. Because of the sheer number of patients who used these two products, the various lawsuits are being consolidated before a federal judge in Massachusetts.

The GranuFlo lawsuits allege that Fresenius Medical Care failed to warn people of the serious risk of fatal cardiac complications. GranuFlo injury attorneys allege that the internal Fresenius memos indicate that the company was aware of the risk of sudden cardiac death and cardiac arrest, stemming from alkalosis.

If you, or someone you love, suffered from cardiac arrest or sudden cardiac death after undergoing dialysis with GranuFlo or NaturaLyte, you have rights. While this can be a very trying event, there are several steps that you can take.

Start by visiting the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Here, you can submit information about your situation. A lawyer specializing in GranuFlo lawsuits will look over your information, free of charge, to help you decide what steps to take next.

 

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Updated April 16th, 2013

 

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2 thoughts onKidney Dialysis Products Linked to Heart Attack, Stroke & Death

  1. Nelson Lee Williams says:

    I have already filled out papers with Attorney’s.
    But i have not been contacted by any of them
    Since May 2012.

  2. Nelson Lee Williams says:

    My brother Anthony Williams was under going Dialysis treatment,at Deveta South on Wayne Memorial Drive in Goldsboro North Carolina,His dialyze tube was put in at Rex Hospitol in Raleigh North Carolina.He passed on Saturday March 10,2012 @3am in the Wayne Memorial Hospitol in Goldsboro NC.He was Memorialized and burried on Thursday March15,2012 in the Barnes semitary in Rosewood beside hisa mother and father.

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