GranuFlo Linked To Cardiac Arrest And Manufacturer Fails To Inform Patients And Doctors

One of the most widely prescribed dry acid products used in the dialysis industry today, GranuFlo, was found to increase patient risk of sudden death from cardiac arrest, according to the New York Times. The manufacturer of GranuFlo, Fresenius Medical Care, treats more than a third of Americans who receive dialysis through their own clinics, or through other clinics where their products are used. Although the company sent a memo to their own clinics explaining the cardiac arrest risk that had been linked to the acid, they failed to immediately warn other centers that use GranuFlo, sparking an FDA investigation.

Dialysis, which takes on the kidney’s role and clears toxic waste from the blood, requires bicarbonate to neutralize the acid that builds up in the blood. Compared to competitor drugs, GranuFlo contains more of the ingredient that the body converts to bicarbonate.

On November 4, 2011 the company’s medical office sent a memo to their dialysis centers that warned against the misuse of the company’s products. The internal memo detailed a study that showed an increased death risk associated with acidosis and high pre-dialysis bicarbonate. According to the memo, 941 patients had suffered cardiac arrest inside the company’s clinics in 2010. High levels of bicarbonate in the patients’ blood increased their risk of cardiac arrest about six times that of patients with low levels of bicarbonate.

Although Fresenius’s centers received the info, the non-company clinics that buy the product to help treat an estimated 125,000 patients did not receive the memo. Doctors at these centers continued to prescribe the drug without knowing about the increased risk of cardiac problems associated with extra bicarbonate.

In late March, the company finally notified its customers, after the F.D.A. received a copy of the internal memo. The F.D.A. issued an alert in late May cautioning against inappropriate prescription and dosing errors. Steven Silverman, director of compliance for the F.D.A.’s medical devices division, notes that the troubled findings should have been addressed urgently in order to keep the patients safe: “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”