GranuFlo, produced and marketed by Fresenius, is a product used to help balance chemicals in the blood during dialysis treatment. It contains an ingredient that metabolizes in the body as bicarbonate. GranuFlo has more of this ingredient in it than competitor products. Studies have shown that elevated bicarbonate levels in dialysis patients increase the risk of patient death. An internal review at Fresenius discovered that 941 patients in 667 Fresenius dialysis clinics died from cardiovascular-related incidents between January 1, 2010 and December 31, 2010.
Fresenius sent a memo to doctors at Fresenius dialysis clinics warning them that the instructions for GranuFlo could be confusing and to consider this when prescribing the product to patients. Unfortunately, Fresenius did not make patients aware of this risk, nor did the company inform doctors or other clinics who purchase and use GranuFlo of the risk. Neither did Fresenius inform the Food and Drug Administration (FDA) of these serious adverse events, even though it’s required to do so by law.
Interestingly, it wasn’t until someone anonymously sent a copy of the internal memo to the FDA three months later that federal drug regulators began to investigate the matter. Fresenius was required to notify patients and recall its products in order to update its labels. Federal lawsuits involving Granuflo have been centralized in Boston, Mass. For more information, contact Frank Woodson or Matt Munson, lawyers in our Mass Torts Section, at 1-800-898-2034 or at Frank.Woodson@beasleyallen.com or Matt.Munson@beasleyallen.com.
Sources: Beasley Allen website and Drugrisk.com
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