GranuFlo and NaturaLyte Linked to Severe Side Effects

The Fresenius manufactured dialysis products GranuFlo and NaturaLyte are used during hemodialysis treatment in order to cleanse the patient’s blood of impurities. Ordinarily this cleansing process is the responsibility of the kidneys, but some individuals require dialysis to facilitate the cleansing of the blood if the kidneys are failing. These products are utilized to assist the patients who suffer from kidney problems to live a normal and healthy life.

These acid concentrate products, however, have an ingredient that converts to bicarbonate during the process of dialysis. This can create a life-threatening circumstance in some people. Bicarbonate is needed to help rid the body of toxins, but an excess amount can cause side effects from GranuFlo and NaturaLyte including low blood pressure, cardiac arrest, cardiac arrhythmia, and metabolic alkalosis. These problems may lead to sudden death in the patients if they are improperly monitored or fail to be treated for their symptoms in a prompt manner.

FDA issues a Class I recall of GranuFlo and NaturaLyte

The Food and Drug Administration (FDA) received reports of adverse health events involving these Fresenius products early in 2012. Months prior to the FDA being alerted, however, Fresenius issued an internal memo regarding these issues. That memo, released in November 2011, was only issued to Fresenius clinics.

The number of other clinics that utilized GranuFlo and NaturaLyte—thousands of them—were not told of the risks involved with these products. The memo was forwarded to the FDA via an anonymous source four months after Fresenius released it internally.

An investigation was launched by the FDA and they issued a Class I recall of the Fresenius dialysis products soon after.

GranuFlo and NaturaLyte lawsuits are filed

The warnings did not help many of the unsuspecting patients who were put in danger due to Fresenius’s decision not to inform facilities that were not their own. In spite of the products being removed from the market, a large number of people have chosen to file lawsuits against the manufacturers of GranuFlo and NaturaLyte due to the company’s decision not to inform the consuming public of the known risks. Some of these individuals seeking compensation have had loved ones suffer severe side effects or even death, allegedly as a result of these dialysis products.