GranuFlo & Naturalyte are two of the most popular dialysis treatments available as of 2016, and both are manufactured by Fresenius Medical. Patients with kidney diseases and renal failure rely on these products to help them maintain an active lifestyle and minimize their symptoms. However, Granuflo and NaturaLyte may be associated with serious side effects and dangers that patients should be aware of before beginning their dialysis treatments.
How GranuFlo & Naturalyte Works
A typical dialysis treatment involves circulating used blood through a dialyzer machine, where the impurities are filtered out before being placed back into the patient’s system. In essence, the machine acts as an artificial kidney. The dialyzer also contains a chemical solution, referred to as a dialysate, which helps to eliminate waste and purifies the blood. GranuFlo is a powdered dry acid compound, while NaturaLyte comes in liquid form. Both products are concentrates that are intended for use in a three-stream hemodialysis machine, which are calibrated for acid and bicarbonate substances.
GranuFlo/Naturalyte FDA Recall
Most of the problems that stem from GranuFlo and NaturaLyte are the result of excessive bicarbonate. In 2012, the FDA issued a Class I recall of both products, stating that the manufacturer must revise the prescription instructions. They went on to report that GranuFlo and NaturaLyte can cause low blood pressure and cardiac arrhythmia, and that these medical issues “may culminate in cardiopulmonary arrest” or other serious conditions. After this recall, evidence was released that indicated Fresenius knew about the possible dangers of their products, but chose not to share the information with the public.
These potentially life-threatening complications that are linked to GranuFlo and NaturaLyte are caused by bicarbonate build-up within the patient’s blood stream. The products contain sodium diacetate, instead of sodium acetate, which is commonly found in many other dialysis products. Thus, it may produce higher levels of bicarbonate, especially if the physicians follow the same dosage instructions as traditional dialysis products.
Patients and their loved ones who have received GranuFlo and NaturaLyte dialysis treatments may be entitled to compensation. Speaking with an experienced legal professional can help them determine if they may be eligible for damages that were incurred as a result of these two Fresenius products.