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Ashcraft & Gerel to Handle GranuFlo Cases

GranuFlo and NaturaLyte are brand names of dialysates manufactured by Fresenius Medical Care which is the world’s largest provider of kidney dialysis services and products.

GranuFlo and NaturaLyte are used in thousands of dialysis centers to treat those individuals with kidney disease or kidney failure. These ingredients are intended to prevent the buildup of dangerous acids that are naturally removed in people whose kidneys function normally.

However, after investigating the serious risks surrounding the use of these kidney dialysis products, the Food and Drug Administration issued a Class I recall of GranuFlo and NaturaLyte on March 29, 2012 to revise prescribing instructions.

According to the recall, the use of these two products can lead to low blood pressure and cardiac arrhythmia. These conditions “may culminate in cardiopulmonary arrest” or other conditions, including death.

The New York Times discovered that Fresenius was aware of the dangers of these drugs and did not share this information with health care providers or consumers. An internal company memo from Nov. 4, 2011, reported that more than 900 patients had experienced heart attacks in Fresenius clinics during the previous year.

GranuFlo and NaturaLyte are still being used in dialysis clinics and have not yet been recalled.

For more information contact Michelle Parfitt or Sara Anderson in the Alexandria, Virginia office at 703-931-5500.