Earlier this year, the Food and Drug Administration issued a Class 1 recall for GranuFlo, an acid concentrate used in dialysis, which is a medical technique that helps eliminate waste materials from the kidneys when a patient can no longer do so without assistance. If you or someone you love has suffered serious injury or health complications from GranuFlo, please contact the drug injury law firm of Altman & Altman, LLP today.
A Class 1 recall means that GranuFlo is considered to be unsafe enough that it may cause serious health issues or even death. Serious side effects linked to this compound include:
• Heart attack • Heart ailments • Very low blood pressure • Lowered potassium levels • Metabolic alkalosis • Stroke • Decreased oxygen levels in the blood • Cardiopulmonary arrest • Higher blood levels of CO2 • Death
Granuflo is one of the two acid concentrates in dialysate, which is what purifies dialysis patients’ blood. It comes in powder or a dry concentrate and mixed with NaturaLyte, which is a liquid concentrate. The solution is watered down and combined with baking soda. (The FDA has also issued a Class 1 recall of NaturaLyte.) The problem developed because both Granuflo and NaturaLyte have sodium acetate and acetic acetate. Because the body converts sodium acetate into bicarbonate, this means that the patient is getting a higher degree of bicarbonate than recommended. Erroneous mixing of the solutions may even raise the bicarbonate level in the body to the point where metabolic alkalosis can happen. This can cause heart arrhythmias and possibly even death.
Considering that hundreds of thousands of Americans undergo dialysis treatment for their kidney failure on a regular basis each year, that GranuFlo can cause such serious complications is definitely cause for concern. Unfortunately, many dialysis patients don’t even know that they’ve receive either Granuflo or NaturaLyte during treatment.
If you suffered health issues or other injuries from taking GranuFlo, you may have grounds for a GranuFlo lawsuit against manufacturer Fresenium Medical Care and others involved in the distribution or sale of this compound. Fresenium is the leading supplier of dialysis machines and disposable products.
In 2011 Fresenium reportedly issued a memo to its facilities acknowledging the dangers involved with GranuFlo, including a 6 to 8 times greater risk of possibly deadly heart attacks. It even reported 941 instances of cardiac arrest following dialysis procedures that were performed in its clinics alone. However, the manufacturer is accused of failing to immediately notify doctors that weren’t practicing in its own dialysis centers, the FDA, and the public about these risks. It wasn’t until March that the federal agency obtained, via an anonymous source, a copy of this internal memo. The FDA announced its recall in June.
Class 1 Recall: Fresenius GranuFlo (powder) Acid Concentrate, FDA, June 25, 2012
Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry, The New York Times, June, 15, 2012
Dialysis , NIH
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