FDA Recalls GranuFlo and NaturaLyte Due to Severe Risks

Sept. 28, 2012 - PRLog -- The FDA has recalled GranuFlo dialysis treatment, in light of evidence that the treatment may increase patients’ risk of heart attack or sudden cardiac arrest by as much as 6 to 8 times.  The recall is a Class I Recall, the most urgent kind of recall, and is only utilized when there is a “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.”

GranuFlo is an acid concentrate component of dialysate. The product is intended for use in hemodialysis treatment of acute and chronic kidney failure. Dialysis may be used to treat other conditions as well. GranuFlo-induced heart attacks and cardiac death typically occur within 48 hours of dialysis treatment.

GranuFlo isn’t the only drug affected by the recall. NaturaLyte, a similar product, is being recalled as well. Both drugs are manufactured by Fresenius Medical Care, which operates more than 1,800 medical centers across the U.S. They do not operate all of these clinics under the Fresenius name, so it can sometimes be difficult to discern whether or not a particular clinic has used GranuFlo or NaturaLyte. To complicate matters even further, these products have also been used in clinics not owned by Fresenius.

Evidence shows that the Fresenius may have hidden the risks for some time. A New York Times article alleged that Fresenius sent an internal memo in November 2011 discussing the increased heart attack risk linked to both dialysis products. The company did not, however, inform consumers, doctors or the FDA about the staggering risks. The New York Times expose charges that Fresenius didn’t even notify the clinics that used the drugs. The FDA did not discover GranuFlo’s dangers until the Fresenius document was anonymously linked to them.

Upon learning of the risks, the FDA immediately conducted an investigation into GranuFlo’s heart attack risks, confirming what the company already seemed to know internally. In June 2012, the FDA issued its Class I Recall. Had the manufacturer come forward with its own findings much earlier, countless people might have been spared from devastating heart attacks and deaths.

At Nadrich & Cohen LLC, our personal injury lawyers are actively investigating cases involving and GranuFlo and NaturaLyte. If you or someone you love has experienced heart attack or sudden cardiac arrest as a result of GranuFlo or NaturaLyte dialysis treatments, give us a call today at 800-718-4658. We will provide you with a free and confidential consultation, and help you to determine whether you may be entitled to compensation. Call us today, or visit us at http://www.personalinjurylawcal.com.