Leaked Internal Memo Reveals GranuFlo Dangers

When Fresenius Medical Care discovered in 2011 that its dialysis concentrates GranuFlo and NaturaLyte had the potential to cause serious complications including heart attacks and arrhythmias if the dosage was not properly adjusted, the company quickly sent out an internal memo to doctors at its own dialysis centers, alerting them to the risk of these GranuFlo side effects. The memo, dated November 4, 2011, warned that “This issue needs to be addressed urgently.”

Yet as urgent as the situation was, the company inexplicably failed to send that memo to the many medical centers and on-site dialysis providers that were not run by Fresenius but that also used GranuFlo and NaturaLyte. The warning remained in-house, while patients who received dialysis treatments from outside providers were left at risk of life-threatening side effects such as GranuFlo heart attack.

FDA investigates Fresenius’ failure to warn

In March 2012, the internal memo was sent anonymously to the FDA, which questioned Fresenius as to why it had not sent the memo to dialysis providers outside its own network. “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 F.D.A.’s medical devices division, told the New York Times.

Following the FDA’s questioning of Fresenius in March, the company did send out a warning to its entire customer base. This was followed by an FDA public safety alert in May 2012, and then a Class 1 NaturaLyte and GranuFlo recall in June 2012.

Deaths from GranuFlo and NaturaLyte

GranuFlo and NaturaLyte both have the potential to raise bicarbonate levels more than other dialysis concentrates. Since doctors were not aware of this, their were not adjusting the dosages properly, which could lead to elevated levels of bicarbonate in the patients’ blood. This in turn could cause a condition called metabolic alkalosis, which can lead to heart attacks, arrhythmias, strokes, and other life-threatening complications.

The Fresenius internal memo noted that in 2010 alone, 941 patients had died of heart attacks after being given dialysis with GranuFlo at Fresenius clinics, and the patients were found to have elevated levels of bicarbonate in the blood.

Patients who suffered complications after receiving dialysis with GranuFlo or NaturaLyte may be eligible to file a lawsuit against Fresenius, and many have already done so.

[SmartLink granuflolawsuit]