Fresenius Is Investigated Due To Failure To Warn Patients of Risk of Death From Granuflo Treatment

The largest hub of dialysis centers, Fresenius, is under the FDA’s microscope after an urgent internal memo, stating that the improper use of GranuFlo leads to a higher risk of death, never reached all centers of Fresenius, nor its patients.

The FDA is investigating Fresenius and GranuFlo, a hemodialysis agent created by the company, only after the internal memo was leaked in March 2012. But because neither Fresenius nor its products division, which markets GranuFlo, had specific reports and numerical data about the adverse effects, Fresenius was never legally bound to make any of the information public.

Although no legal obligations were present, Steven Silverman, director of compliance for the FDA’s medical devices division, states that, “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”

Dialysis is normally required for patients who have too much acid in their blood (acidosis). By pumping bicarbonate into a patient’s body, the acid can be neutralized (a process known as hemodialysis). GranuFlo is a source of that bicarbonate, and it contains more of the bicarbonate solution than that of its rivals. This can lead to a bicarbonate overdose which results in cardiac complications.

Patients who were affected by the GranuFlo treatment saw symptoms such as heart attack, cardiopulmonary arrest, stroke, sudden death and serious heart injury within 48 hours after receiving the treatment.

The memo stated that found that within Fresenius clinics in 2010, 941 patients had suffered cardiac arrest. In comparison with other patients not treated with GranuFlo, Frenesius’ staff was able to deduce that patients with high bicarbonate levels had around six times the risk of cardiac arrest.

Fresenius’ full report, dated November 4, can be seen here.