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Adverse affects of GranuFlo being investigated
Hundreds of thousands of Americans receive dialysis for kidney failure – and Fresenius Medical Care treats a significant number of those patients. The U.S. Food and Drug Administration is investigating whether the country’s largest operator of dialysis centers failed to inform patients abouts the adverse affects of GranuFlo, a substance used in the blood-cleansing procedure.
The FDA announced a Class I recall of dialysis products GranuFlo and NaturaLyte in June 2012 – linking Fresenius Medical Care with health care concerns around the country, in particular heart attack and death.
According to The New York Times, the FDA is investigating whether Fresenius violated federal regulations by failing to inform physicians and patients of a potentially lethal risk connected to Granuflo. An internal memo obtained by the Times appears to indicate that the company knew about the dangerous side effects of GranuFlo and failed to warn of the risks associated with the product.
GranuFlo has been used to treat over 275,000 patients in more than 2,700 kidney dialysis clinics throughout North America, Europe, Asia, Africa and Latin America.
A medical treatment prescribed for people with kidney failure, dialysis does the kidneys’ job of clearing toxic waste in the blood. Part of the dialysis process involves taking bicarbonate to neutralize acid in the blood. During hemodialysis, a patient’s blood is circulated through a machine, cleansed of impurities and reintroduced to the body in purified form. GranuFlo is used to evenly distribute electrolytes during dialysis – however an active ingredient in GranuFlo converts to bicarbonate. Elevated bicarbonate levels – from the combination of prescribed bicarbonate and that produced by GranuFlo – could result in metabolic alkalosis, a condition which can generate deadly effects including cardiopulmonary arrest, heart attack and stroke.
Dangerously high levels of bicarbonates in the dialysis treatment may have impacted thousands of dialysis patients nationwide.
Currently, there are more than 200 actions pending in the GranuFlo Multi-District Litigation (MDL). All involve allegations that plaintiffs suffered injury or death caused by the use of GranuFlo during hemodialysis – potentially resulting in low blood pressure, heart attack, cardiac arrhythmia or stroke.
According to news reports, the failure of Fresenius Medical Care to warn about the significant health risks associated with elevated bicarbonate levels could have led to numerous preventable health issues.
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