Federal health regulators are investigating Fresenius Medical Care, the largest operator of dialysis centers in the U.S., for failing to warn its customer clinics of a serious risk of heart attack and death related to the use of its GranuFlo dialysis drug. GranuFlo can contribute to elevated bicarbonate levels in patients, leading to hemodialysis metabolic alkalosis, a significant risk factor for a variety of heart and health problems, including:
- Hemodialysis cardiac arrest
- Dialysis heart attack
- Hemodialysis cardiopulmonary arrest
- Low blood pressure
- Cardiac arrhythmia
- Dialysis death
According to a report from The New York Times, at least 941 people are known to have suffered sudden cardiac arrest while undergoing dialysis with GranuFlo. While Fresenius warned doctors at its own hemodialysis facilities, it was only months later that its customers were warned of the heart attack and death risk associated with GranuFlo, and a similar product called NaturaLyte.
According to the Times, Fresenius is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own. Its GranuFlo product is an alkaline substance administered to dialysis patients to neutralize the acid that builds up in the blood. GranuFlo, which is given in conjunction with bicarbonate, contains an ingredient that the body converts to bicarbonate. However, compared to rival products, GranuFlo contains far more of this ingredient.
Fresenius GranuFlow Cardiac Arrest Memo
Last November, Fresenius issued a memo to doctors working at dialysis centers it owns warning them that 941 patients at its clinics had suffered sudden cardiac arrest in 2010. According to the November 4 memo, doctors had not been accounting for the higher bicarbonate contribution from GranuFlo or NaturaLyte when deciding how much bicarbonate to prescribe separately. The company’s medical staff concluded that dialysis patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.
In addition to its Fresenius-owned dialysis centers, the company sells GranuFlo and NaturaLyte to customer clinics throughout the U.S. According to the Times, roughly 125,000 patients in non-Fresenius clinics are treated with GranuFlo. However, Fresenius did not bother to issue the same warning to any of those clinics last November.
FDA Fresenius GranuFlow Investigation
According to The New York Times, Fresenius finally did issue a warning to its customers in March 2012, after the U.S. Food & Drug Administration (FDA) received a copy of the November memo from an anonymous source. The FDA is now investigating Fresenius to determine if it violated federal regulations by failing to inform its customer clinics about the potentially risk of heart attack and sudden death associated with GranuFlo and NaturaLyte.
“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the FDA’s medical devices division, said in an interview with The New York Times.
In May, the FDA issued a warning to dialysis clinics nationwide stating that “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” According to the agency, when metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with a number of serious side effects, including cardiopulmonary arrest, low blood pressure, cardiac arrhythmia and death, the agency said.
In addition to GranuFlo and NutraLyte,