The United States Food and Drug Administration (FDA) is currently investigating the manufacturers of the dialysis drug GranuFlo. The FDA believes there is a very serious defect with this product as well as a failure of the manufacturer to adequately warn doctors and patients of the possible outcomes associated with the use of GranuFlo.
GranuFlo is a widely prescribed drug that is used during dialysis treatment to distribute electrolytes in the patient’s blood. One of the active ingredients in GranuFlo converts itself to bicarbonate during the dialysis process. This, in and of itself, is not a bad thing. The problem arises when the patient accumulates too much bicarbonate in their system. This occurs because bicarbonate is already used in dialysis treatments to neutralize acids in the blood. So the regular bicarbonate treatment when mixed with the bicarbonate conversion of GranuFlo can lead to metabolic alkalosis, which could potentially be fatal.
According to a New York Times article, GranuFlo manufacturers were aware of the issues, but instead of informing the public at large about the problems, they chose to only report the problem via an internal memo. In addition to laying out the potentially fatal side effects, the memo also stated that due to GranuFlo usage, 941 patients had suffered cardiac arrest inside of dialysis treatment centers in 2010.
Based on the information contained in the New York Times article and the FDA, the manufacturer of GranuFlo failed to warn dialysis clinics, doctors, and patients about the potentially lethal side effects associated with their drug. As a result, many dialysis patients have suffered massive heart attacks and strokes within 48 hours of receiving GranuFlo.
If you or a loved one has suffered a heart attack or stroke during or within 48 hours of receiving a dialysis treatment, contact the experienced attorneys at The Talaska Law Firm today for your free consultation. Let the The Talaska Law Firm fight for you or your loved one against the manufacturer of GranuFlo.