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GranuFlo & NaturaLyte Recall


 

When the U.S. Food and Drug Administration (FDA) issued a NaturaLyte and GranuFlo recall for the dialysis drugs in June 2012, the agency continued to investigate their potential to cause catastrophic heart injuries and even sudden cardiac death. These side effects have prompted more and more patients to file Granuflo lawsuit.

Now, the number of claims filed against GranuFlo’s manufacturer, Fresenius USA, is growing in courts throughout the U.S. on behalf of patients who suffered the following injuries:

  • cardiovascular death
  • sudden cardiac death
  • cardiopulmonary arrest
  • heart attack
  • other catastrophic heart injuries

granuflo recallThese GranuFlo side effects will most likely occur within 48 hours of the patient undergoing a dialysis treatment using GranuFlo and NaturaLyte, which are acid concentrates used to neutralize the acid that builds up during dialysis treatments.

A particularly disturbing aspect of the manufacturer’s distribution of GranuFlo and NaturaLyte is how often the drugs were used in dialysis treatments prior to the Fresenius Granuflo recall. Fresenius USA operates dialysis clinics at over 125,000 facilities, and is the largest dialysis products and services company in the U.S. and around the world. Further, Fresenius operates over 1,800 kidney dialysis clinics in the U.S. alone. The products were also used by thousands of independent dialysis clinics prior to the GranuFlo recall.

GranuFlo Recall Prompted By Reports of Cardiac Injuries, Death

While GranuFlo is an acid concentrate powder and NaturaLyte is a liquid, both medications contain an ingredient the body works to convert to bicarbonate. Rival dialysis drugs also contain this ingredient, but GranuFlo and NaturaLyte contain more, which may cause patients to become more susceptible to a condition referred to as alkalosis. This condition is linked to an increase in cardiovascular death, heart attacks, other heart-related injuries for those undergoing dialysis treatments.

Further, it appears that Fresenius USA was aware of the potential for cardiac injuries and dialysis death to stem from GranuFlo and NaturaLyte. Around the time the FDA issued the GranuFlo recall, the agency anonymously received a copy of an internal memo sent by the company to the doctors operating in its dialysis clinics, warning them that improper use of GranuFlo and NaturaLyte may contribute to sudden cardiac death. According to the letter, 900 cardiac deaths had been linked to GranuFlo and NaturaLyte in 2010.

The GranuFlo recall was then categorized by the FDA as Class I, the most serious type of recall only issued when the FDA deems there to be a high likelihood that a product may lead to serious side effects and/or death.