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FDA Issues GranuFlo Recall

The Food and Drug Administration issued a recall of the dialysis products GranuFlo and NaturaLyte on the 29th of March, 2012, after a memo from drug maker Fresenius Medical Care was leaked to the public. These products are used during hemodialysis in order to remove toxins from the bloodstream of a patient whose kidneys are not functioning properly; however, GranuFlo and NaturaLyte have been linked to an increased risk of heart attack and sudden death. A number of patients who have experienced these side effects or whose loved ones have experienced them have filed suit against the drug manufacturer in the hopes of gaining compensation for the injuries.

Dangerous side effects linked to products

GranuFlo and NaturaLyte are similar products which were both designed to reduce the build-up of acid in the blood and to utilize bicarbonate in order to neutralize acids. However, these products are different from their competitors in that they use greater concentrations of bicarbonate, which can lead to serious health issues especially if doctors miscalculate the proper and safe dosage. Fatal overdoses, which can cause sudden death, and heart attacks are the most serious side effects of this product.

Fresenius Medical Care published an internal memo on the 4th of November, 2011, regarding risks associated with their product. A reported 941 patients had suffered heart attacks linked to the use of these products, and the memo detailed these “troubling findings”. Medical staff were informed that the problem needed to be “addressed urgently.” However, no contact was made with the Food and Drug Administration about these concerns, and no public warning was issued to patients at risk for GranuFlo related side effects. The memo was leaked to the Food and Drug Administration, which prompted a recall of the products.

Recall leads to individual lawsuits

Patients alerted to the recall suddenly may have been able to connect adverse health events that they had experienced to the use of GranuFlo, and many have hired GranuFlo attorneys in an effort to seek compensation that could help cover injury-related costs they have accumulated.

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