Questions and Answers About Fresenius and its Dialysis Products GranuFlo and NaturaLyte

Questions abound about the Fresenius dialysis products GranuFlo and NaturaLyte including desired information about the FDA recall of the medication GranuFlo, life-threatening risks from taking the drugs, and the FDA investigation surrounding them. Many patients have filed lawsuits against the manufacturer with more sure to follow.

An overview of the basic information follows.

Fresenius Medical Care

Fresenius provides its medications and dialysis machines to many nursing homes, medical clinics, and other health-based facilities as well as its own. The largest operator of kidney dialysis centers in the United States, Fresenius is based in Germany. As many as one-third of the 400,000 dialysis patients in the U.S. are treated at Fresenius clinics. In addition, the company is the leading supplier of dialysis products and machines in the country. Fresenius also manufactures the dialysis medications NaturaLyte and GranuFlo.

GranuFlo and NaturaLyte—what they are and what they do

Used to help reduce acid buildup in the blood during dialysis, GranuFlo and NaturaLyte are acid concentrates . GranuFlo is the powder form of the drug, while NaturaLyte is the liquid form.

The FDA’s investigation into Fresenius

According to a November 4, 2011, memo sent to doctors in its own network of dialysis centers, a serious risk is present when using NaturaLyte and GranuFlo. The memo states that both medications have the potential to raise the level of bicarbonate in the blood of patients more than other dialysis concentrates.

Unaware of this risk, doctors were failing to adjust their patients’ dosages of the concentrates appropriately. This could cause an overdose of bicarbonate, leading to a condition known as “metabolic alkalosis.”

Metabolic alkalosis is a pH imbalance in the body. It can cause cardiac problems such as heart attacks and arrhythmias.

A website estimates the number of patients treated with the drugs after the memo and the FDA recalls the drug

A website devoted to dialysis, RenalWeb, estimated that 125,000 dialysis patients in non-Fresenius clinics had been treated with NaturaLye and GranuFlo without having been warned of the risks. These individuals may have grounds to file a lawsuit against Fresenius.

The FDA became aware of the memo in March of 2012. The FDA pressured Fresenius and the company sent out a warning to dialysis centers outside of their network on March 25, 2012. This was four months after the warning to their own doctors was issued.

A Class I recall—the most urgent—was implemented by the FDA on June 27, 2012. That level of recall is for products that it has been determined “may cause serious adverse health consequences, including death.”

Patients have died from side effects of GranuFlo and NaturaLyte

The memo states that in 2010, 941 patients who died after having a heart attack at Fresenius dialysis centers had elevated bicarbonate in their blood. This indicates that they suffered a heart attack after using GranuFlo.

In the memo, these findings were referred to as, “troubling.” It also said, “This issue needs to be addressed urgently.”

In November 2011, the company sent this memo to its own centers. They failed to send it to the remainder of their customers including on-site dialysis providers, medical centers, and nursing homes.

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