I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on June 29, 2012, 01:46:22 AM
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Class I Recalled Issued for Fresenius NaturaLyte, GranuFlo Dialysis Products
Posted on June 28, 2012 by Laurie
Federal regulators are issuing a Class I recall for Fresenius Medical Care’s NaturaLyte and GranuFlo dialysis products. As we’ve reported previously, dosage errors involving GranuFlo and NaturaLyte have been implicated in more than 900 cases of cardiac arrest at Fresenius-owned dialysis clinics.
A Class I recall is the U.S. Food & Drug Administration’s (FDA) most serious category, and is issued for products that pose a risk of serious injury or death.
According to the FDA’s recall notice, the inappropriate prescription of GranuFlo or NaturaLyte can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia. These conditions can potentially lead to cardiopulmonary arrest. According to the FDA, GranuFlo or NaturaLyte may cause serious adverse health consequences, including death.
Both GranuFlo and NaturaLyte are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body. Cardiac arrest can occur if a doctor does not account for the higher bicarbonate contribution from GranuFlo or NaturaLyte when deciding how much bicarbonate to prescribe separately.
Earlier this month, The New York Times reported that the FDA is now investigating Fresenius to determine if it violated federal regulations by failing to inform its customer clinics about the risk of heart attack and sudden death associated with GranuFlo and NaturaLyte. According to the Times, Fresenius had issued a memo to its own clinics late last year warning them of the potential risks associated with the two products. According to the November 4 memo, 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. An analysis the company conducted indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients.
While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the public or the FDA about the findings until the agency received an anonymous copy of the memo and inquired about it. Fresenius only issued a warning to its customer clinics this past March, after the FDA began asking questions.
http://www.newsinferno.com/defective-medical-devices/class-i-recalled-issued-for-fresenius-naturalyte-granuflo-dialysis-products/39096
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okarol, have I ever told you how much I appreciate your keeping us up-to-date on the news? It's invaluable. Thank you. :flower;
I really don't have much to say because this scares the absolute bejeesus out of me. I've been using this stuff for almost two years now. Look at the first symptom listed: low blood pressure. It probably wouldn't worry me if I had any faith in my doctor. I asked her about lowering the bicarb when I made the switch to the higher calcium bath and she said, "Just wait and see". Looks like I have my topic for my next visit. Meanwhile, does anyone know how much acetate should be in the acid? That would be helpful to know.
And how do they call this a 'recall' when nothing is actually being recalled? This stuff is killing people and they're shoving it off on the doctors by saying they just have to prescribe more carefully. Well, hell, what does that then say about their own doctors?
Worst of all, the bastards knew. They KNEW and didn't say one word until the FDA (thank goodness for THAT little government agency) started sniffing around. They should be forced to physically recall all the Naturalyte and pay to have their 'customer clinics' obtain it from an alternate source until they can get their sh*t together. They let people die to protect their profit margin. Heads should roll.
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DD, you're a smart lady. What does your gut tell you? Do you suspect that your recent problems is due to incorrect dosing of Granuflo?
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DD, you're a smart lady. What does your gut tell you? Do you suspect that your recent problems is due to incorrect dosing of Granuflo?
Actually, I don't; however, if things don't come up (and stabilize) from the increased calcium it might be something I have to consider.
I've never used the Granuflo (just threw out the one carton I had). I've always used the NaturaLyte and my item/stock numbers were on the recall.