Fresenius Medical Care is the largest operator of hemodialysis clinics in the United States. Operator of the nation’s largest dialysis center and manufacturer of dialysis drugs, Fresenius Medical Care, has recently failed to inform consumers of potentially lethal risks involved with their products, GranuFlo & NaturaLyte.
November 4, 2011, Fresenius sent a memo internally to their company that warned of a significant increase in the risk of heart attacks associated with use of their drugs GranuFlo & NaturaLyte. The Fresenius memo warned doctors working in the company’s own clinics. The Fresenius memo however did not warn other centers of the dangers until late March 2012, when the Food and Drug Administration (FDA) received an anonymous copy of the original company memo. Meanwhile as the German based Fresenius company withheld the vital information, over 125,000 estimated patients were using GranuFlo & NaturaLyte in facilities not owned by Fresenius. Fresenius Medical Care failed to disclose this critical information to the government or health care providers, allowing continued high dose administration of the drug to high-risk patients and ultimately has led to avoidable injuries and deaths.
GranuFlo & Naturalyte are the most widely prescribed dry acid products for patients undergoing dialysis. GranuFlo & NaturaLyte are both powder-based drugs that contains an ingredient, which the body converts into bicarbonate. GranuFlo & NaturaLyte, when combined with other medical products, helps patients with kidney failure in the dialysis process by creating bicarbonate to help clean the bloodstream, which they otherwise would be too weak to do. Bicarbonate essentially acts as a chemical buffer, keeping the blood from becoming too acidic or too basic. Because so many doctors were not warned of the higher level of bicarbonate already present in their patient’s bloodstream, they were not taking this into account when prescribing them additional bicarbonate in the GranuFlo & NaturaLyte products. The FDA has found that doctors were giving GranuFlo & NaturaLyte at levels too high for healthy human compensation, leading to an increased risk of heart attacks. This overdose caused by the NaturaLyte & GranuFlo’s additional bicarbonate therefore led to a six to eightfold increase in risk of cardiac arrest. Cardiac arrest is the #1 cause of death among dialysis patients, accounting for 39% of all cause deaths.
In addition, GranuFlo & NaturaLyte have been found to cause cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, and death.
Fresenius is currently under investigation by the FDA to see whether the company violated federal regulations by not alerting all customers of GranuFlo & NaturaLyte of the health risks. The FDA issued a Class 1 recall of GranuFlo & NaturaLyte from all clinics on June 27, 2012.
If you or a loved one has experienced cardiac arrest, heart attack, stroke following dialysis with GranuFlo or Naturalyte, please contact the Willis Law Firm for a free consultation for a potential dialysis lawsuit. Call 1-800-883-9858 to speak to lawyer or CLICK HERE