FDA Issues Class I Recall of GranuFlo and NaturaLyte

Article curtesy of Seeger Weiss LLP.

On June 27th, 2012, the Food and Drug Administration (FDA) issued a Class I recall of the dialysate concentrates GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate. These products are manufactured by Fresenius Medical Care North America (FMC). A Class I recall is reserved by the FDA for the most serious of cases in which the medications are likely to cause serious side effects and/or death. GranuFlo and NaturaLyte contain higher levels of alkaline chemicals (acetate and acetic acid) than other dialysates, and this can result in excessive alkalines in the blood stream and possibly lead to metabolic alkalosis. Metabolic alkalosis is an extremely dangerous condition known to cause the following symptoms and side effects: Cardiac Arrhythmia – irregular heartbeat; Cardiopulmonary Arrest; Hypercapnia – excessive carbon dioxide levels in the blood; Hypokalemia – low potassium levels in the blood, which the heart and other muscles require to function correctly; Hypoxemia – low oxygen levels in the blood; and Low Blood Pressure.

GranuFlo and NaturaLyte are dialysates, substances which physicians can use to treat kidney (renal) failure. The main function of the kidneys is to maintain the body's pH level and clean waste chemicals from the blood stream. In renal failure, these waste chemicals build up in the blood stream making the body's pH levels more acidic. Dialysates include chemicals that the body can convert into the alkaline substance bicarbonate. Bicarbonate can neutralize some of this acidic waste chemical buildup.

In November 2011, Fresenius sent an internal memo to physicians at their 1,800 dialysis treatment clinics. This memo noted that many doctors were prescribing GranuFlo and NaturaLyte in doses too high to be safely used by humans. Some physicians were not aware that the medications contained much higher levels of alkaline chemicals than competing products. It specifically mentioned that dosing errors sometimes happened when doctors substituted Naturalyte with GranuFlo, as the products required different dosage levels that were not always taken into account. It also alerted the clinics that in 2010, these higher levels of alkaline chemicals in GranuFlo had caused 941 cases of cardiac arrest in hemodialysis patients in their own clinics. Fresenius researchers had determined that using GranuFlo would increase a patient's risk of heart attack six fold. The company did not, however, notify the FDA or independent clinics not owned by Fresenius that were still using GranuFlo and NaturaLyte.

The FDA received the anonymously leaked memo in March 2012, and launched an investigation into Fresenius inaction regarding their potentially deadly products. They have since publicly condemned the company, whose GranuFlo and NaturaLyte products were being used by as many as 350,000 patients. The FDA determined that when inappropriately prescribed, these products can cause high serum bicarbonate levels in patients undergoing hemodialysis and that this condition may cause serious adverse health consequences, including death.

Disclaimer: The information on this page does not constitute legal advice and should be considered general information only. If you or someone you know has taken GranuFlo or NaturaLyte and been harmed by the inaction and deception of Fresenius Medical Care North America, please contact Seeger Weiss LLP directly.