GranuFlo and Metabolic Alkalosis

In November 2011, Fresenius Medical Care sent an internal memo to doctors in its network of dialysis centers, warning of the risk of adverse side effects from using GranuFlo and NaturaLyte – specifically, the risk of bicarbonate overdose leading to metabolic alkalosis, which can cause arrhythmias, heart attacks, and death.

What is metabolic alkalosis?

Metabolic alkalosis is a pH imbalance in the body. The initials “pH” stand for “potential of hydrogen”, and refers to the measure of hydrogen ions in a solution (such as blood). A normal pH level in the blood is 7.35 to 7.45. Any significant deviation from this norm can have dangerous consequences to the person’s health.

Dialysis is used to clean and purify the blood of patients whose kidneys can no longer function properly. During this process, acid can build up in the blood to a dangerous level, throwing off the pH balance. Concentrates like GranuFlo and NaturaLyte are used to lower the acid level. However, GranuFlo and NaturaLyte can raise bicarbonate levels in patients’ blood more than other dialysis concentrates. Since doctors were not aware of this, they were not properly adjusting the dosage of GranuFlo and NaturaLyte, and as a result, patients were getting too much bicarbonate in their blood, causing the blood to become too alkaline and throwing off the pH balance.

Metabolic alkalosis occurs when the blood is too alkaline, upsetting the pH balance. When this happens, sodium and potassium levels drastically decrease, causing symptoms including headaches, nausea, shallow breathing, cramps, and diarrhea. If the metabolic alkalosis becomes more severe, the person may suffer life-threatening consequences including arrhythmias, a drop in blood pressure, hyperventilation, seizures, convulsions, or heart attack. In fact, 941 patients died of heart attacks at Fresenius centers in 2010 after having dialysis with GranuFlo or NaturaLyte, and those patients were found to have high bicarbonate levels in their blood.

GranuFlo recall

In June 2012, the FDA issued a Class 1 recall of GranuFlo and NaturaLyte. A Class 1 recall is the agency’s most urgent category of recall, used for products deemed dangerous.

Although Fresenius had warned its own dialysis centers about the danger of metabolic alkalosis from GranuFlo in its November 2011 memo, the company did not warn dialysis providers outside its own network who used GranuFlo and NaturaLyte. Therefore, those patients were left at risk for several months, until the FDA forced Fresenius to warn those other dialysis providers in March 2012.

Because Fresenius knew about the risk but did not warn all dialysis providers, patients who suffered metabolic alkalosis after undergoing dialysis with GranuFlo or NaturaLyte have been filing lawsuits against GranuFlo manufacturer Fresenius, charging that the company knowingly put them at risk and failed to warn them of the danger.

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