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Kidney Dialysis Drug, GranuFlo, Recalled by the FDA—Find Out Why

January 9th, 2015 Defective Products

On March 29, 2012, the FDA issued a Class I recall of GranuFlo, a kidney dialysis drug manufactured by Fresenius Medical Care. Because Class I recalls are only issued when the FDA determines a product can cause severe complications or death, this makes Fresenius liable for patient injuries and deaths. Recent reports show GranuFlo increased patient risk of entering cardiac arrest by six times. If you or someone you know has undergone dialysis treatments using GranuFlo, the time to take action is now.

What Makes GranuFlo Defective?

GranuFlo was released to the market in 2003, and by 2010 it was the most widely prescribed dry acid concentrate for dialysis. Fresenius claimed that due to its unique formula, it was the safest drug on the market and the drug was then sold to dialysis centers and clinics across the country.

The formula for GranuFlo included sodium diacetate as the active ingredient, which has both bicarbonate and acetate parts. These ingredients are meant to neutralize the excess acids in blood for patients suffering from failing or damaged kidneys. However, through the dialysis process, the blood treated with GranuFlo returns to the body and the liver converts the acetate into bicarbonate. With the increased levels of bicarbonate in the blood, this doubles a patient’s chances of having a heart attack or other cardiovascular events.

Fresenius’s GranuFlo Patient Surveys

In 2010, Fresenius distributed a survey among patients who had been treated in its clinics and established that almost 1,000 patients had suffered heart attacks. This finding was unfortunately not communicated publicly by the company for a whole year. In November 2011, Fresenius issued an internal memo to its clinics across the country warning them of the dangers GranuFlo posed to their patients.

The survey also found that apart from increasing chances of cardiac arrest by six times, GranuFlo caused several other complications. GranuFlo patients also reported suffering from irregular heartbeat, strokes, and low blood pressure. Levels of carbon dioxide in the blood also increased and in turn reduced the levels of oxygen flow. This information was not communicated to other dialysis centers which used the drug or to the FDA.

The FDA’s GranuFlo Recall

A copy of the internal memo Fresenius had issued to its clinics was anonymously received by FDA in March 2012 and the agency took immediate action by issuing Class I GranuFLo recall. The FDA also invited consumers and health care professionals to report any reactions or problems they had experienced from the use of the drug. This has since triggered a long list of GranuFlo lawsuits being filed against Fresenius across the country by patients and loved ones affected by this drug’s side effects.

Current GranuFlo Lawsuits

Patients nationwide who underwent dialysis treatments using GranuFlo and experienced these terrible side effects have filed lawsuits against Fresenius for concealing the dangers of their drug. Additionally, those who lost their loved ones due to complications from taking GranuFlo have also filed lawsuits to bring the manufacturer to justice. In these cases, claimants are holding Fresenius responsible for endangering lives by withholding vital clinical information from the FDA and the public and for irresponsibly marketing the safety of GranuFlo to potential dialysis patients. This entitles those affected to compensation for their medical bills, lost wages, funeral expenses, and mental and physical pain.

If you or a loved one were directly harmed by GranuFlo, it is not too late to file your own lawsuit claim. The first trials are set for 2016, so you can still submit your GranuFlo case for a free legal review with Nolan Caddell Reynolds or call 1-866-242-0452 to see if your experience qualifies you for legal compensation. We will handle your case with dignity and respect on contingency fee basis, which means you only pay for our support if you win your GranuFlo lawsuit against Fresenius Medical Care.


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