Pharmaceutical

Fresenius delayed warning of deadly side effects from dialysis products GranuFlo, NaturaLyte

dialysis Fresenius delayed warning of deadly side effects from dialysis products GranuFlo, NaturaLyteWhen Fresenius Medical Care, the world’s largest provider of dialysis products and services, issued a recall in March 2012 of its dialysis products GranuFlo and NaturaLyte in order to update dosing instructions on the safety labels, the company had known for months that the instructions were confusing and could lead to potentially deadly unintended overdoses of bicarbonate.

According to RenalWEB, Fresenius management was first clued in to a possible connection between dosing errors with GranuFlo and cardiovascular-related deaths in dialysis patients as early as April 2009, during a 4-day professional conference. At that meeting, sudden cardiac death was identified as the No.1 cause of death for dialysis patients, accounting for 59 percent of cardiovascular-related deaths. As a result of the conference, several leading nephrologists reduced sodium levels in dialysate products such as GranuFlo and made other adjustments in the fluids given to dialysis patients.

This led to an internal investigation of cases of cardiopulmonary arrest in patients at Fresenius dialysis clinics between Jan. 1, 2010 and Dec. 31, 2010. That study identified 941 patients in 667 Fresenius facilities who had cardiopulmonary arrests while being treated at Fresenius dialysis clinics. Data also showed that patients who had pre-dialysis bicarbonate levels were 4.7 to 6.3 times more likely to experience cardiac arrest.

Instead of issuing a recall of the products, Fresenius sent an internal memo in November 2011 to doctors at its clinics explaining that dosing instructions on the drug’s label could be confusing. GranuFlo contains a higher level of an ingredient that metabolizes to bicarbonate, so they noted that doctors could be unknowingly exposing patients to bicarbonate toxicity, which could lead to cardiovascular complications, including sudden cardiac arrest.

The company did not warn doctors at other clinics where GranuFlo and NaturaLyte are used, nor did the company warn patients of the risk of death with their products. It wasn’t until the Food and Drug Administration (FDA) received an anonymous copy of the internal memo in March 2012 that a recall was ordered and others were warned of the potential dangers with GranuFlo and NaturaLyte. As a result, Fresenius is facing hundreds of wrongful death and personal injury lawsuits.

If Fresenius had acted in a more proactive manner, issuing a recall as soon as it identified a link between GranuFlo and cardiac arrests in dialysis patients, not only would hundreds of patients likely still be alive, but the company would probably be suffering from far fewer legal problems.

Source: FDA