Severe Adverse Effects Associated with GranuFlo may have Caused 11 Deaths

11 recorded deaths have been attributed to dialysis treatment using Granuflo and Naturalyte, according to online news sources. Subsequently, the people close to the alleged victims filed a Granuflo lawsuit against the manufacturer of the dialysis product, Fresenius Medical Care, demanding recompense for all the pain and suffering they went through. These fled claims were from various courts in the United States, including Georgia, Ohio, Kentucky, Virginia, Texas, Illinois, California, and Florida. According to released court documents, the death of the alleged victims happened between 2010 and 2012.


Granuflo and Naturalyte are dry acid concentrates utilized in dialysis. These dialysates are manufactured and distributed by Fresenius Medical Care, the main dialysis facility operator in the United States. They were first introduced to the market in the year 2003, after which they became very popular. Despite their popularity, however, many dialysis patients reportedly developed severe complications after using the products. In light of this troubling news, the manufacturer launched research studies in order to regulate the situation.


According to the studies, use of Naturalyte and Granuflo increases the risk of heart attacks and strokes. Apparently, many of the patients involved in the study developed heart-related complications after being administered with the dialysis products. In fact, some patients have reportedly died due to the severity of their conditions.


When results of the studies reached Fresenius, the company released a warning memo to its own dialysis centers straight away. It had, however, neglected to immediately warn other facilities using the products. Be that as it may, the U.S. Food and Drug Administration (FDA) was anonymously sent a copy of the company’s internal memo a year later, which impelled the agency to issue a class I recall of Naturalyte and Granuflo.


Following the recall of Granuflo and Naturalyte, several patients allegedly injured by the products filed a lawsuit against the manufacturing company, Fresenius Medical Care. These lawsuits claim that use of the dialysates may possibly cause lethal complications, such as heart attacks, strokes, and other heart-related adverse effects.



http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm