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FDA Warns of NaturaLyte and GranuFlo Side Effects

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On May 25, 2012, the FDA warned healthcare practitioners that incorrect use of GranuFlo and NaturaLyte acid concentrates during dialysis could result in serious side effects. About a month later, on June 27, 2012, the agency issued a Class I recall notice for Fresenius Medical Care products NaturaLyte and GranuFlo, two acid concentrates that were linked with cardiac arrhythmia and sudden cardiac death.

Company Memo Reveals Potential for GranuFlo Side Effects

Fresenius Medical Care is a leading provider of dialysis procedures in North America. Patients who are suffering from kidney dysfunction often have to go through dialysis to cleanse the blood of toxins.

According to the company’s website, GranuFlo is “the most widely prescribed dry acid product in the dialysis industry today.” An internal company memo released November 4, 2011, however, noted that the GranuFlo had a different formula than former concentrates, which could create dangerously high levels of bicarbonate in the blood if doctors failed to adjust the dosage.

Other acid concentrates consist primarily of acetic acid, but GranuFlo and NaturaLyte contain acetic acid plus sodium acetate, which the body may convert into bicarbonate. The memo also noted that according to a case-control study, an elevated level of bicarbonate is an independent risk factor for severe cardiac side effects, including cardiac arrest and death.

GranuFlo Can Lead to High Bicarbonate Levels

Bicarbonate is a natural salt that helps alkalize the blood. Many acid concentrates like NaturaLyte and GranuFlo are metabolized by the body into bicarbonate, helping to reduce acid buildup that can occur during dialysis procedures.

Too much bicarbonate, however, creates a pH imbalance called metabolic alkalosis, which simply means that the blood has become too alkaline. In its May 2012 warning, the FDA noted that metabolic alkalosis is an independent risk factor for low blood pressure, low blood oxygen, high blood carbon dioxide, heart rhythm problems, and sudden cardiac death.

The internal memo from Fresenius warned doctors of the risk of GranuFlo side effects when using these concentrates. It advised doctors to check bicarbonate levels in patients before dialysis, and to adjust prescriptions as necessary. The company failed, however, to warn outside clinics of the risks associated with GranuFlo and NaturaLyte.

FDA Investigation Prompts Second Warning

It was not until the FDA received an anonymous copy of the November memo, and asked Fresenius about it, that the company issued a second warning to outside medical centers and nursing homes concerning GranuFlo side effects. This second communication was not released until March 29, 2012. Between November and March, many patients may have been put at unnecessary risk of serious health events.

In the June 27 Class I recall, the FDA noted that inappropriate use of GranuFlo and NaturaLyte products “can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” They added that, “this product may cause serious adverse health consequences, including death.”

Those patients injured by the incorrect use of GranuFlo or NaturaLyte may be eligible for a lawsuit.