The FDA has issued a Class 1 Recall of dialysis medications GranuFlo (powder) and Naturalyte (liquid). Both products are used during dialysis and are linked to lethal heart attacks in patients. A Class 1 recall is the most serious FDA recall.
The FDA is also investigating why product manufacturer, Fresenius, waited until March 2012 to warn the public about the increased heart attack dangers of GranuFlo and Naturalyte, despite its internal warning to its own dialysis clinics in November 2011. In fact, the FDA found Fresenius did not warn the public until after an internal Fresenius memo was leaked to the FDA. The FDA is investigating whether Fresenius violated federal regulations.
Who is Fresenius?
Based in Germany, Fresenius is the largest operator of dialysis treatment centers in the United States. Fresenius treats more than a third of the 400,000 Americans receiving dialysis. Fresenius is also the leading manufacturer of dialysis machines, products and medications, such as GranuFlo and Naturalyte.
What are GranuFlo and Naturalyte and why are they so dangerous?
Dialysis is used to clear toxic waste from the blood when someone’s kidneys are not functioning properly. During dialysis, bicarbonate is added to neutralize acid that also builds up in the blood.
Two of these bicarbonate-containing products are GranuFlo and Naturalyte. However, in addition to containing bicarbonate, GranuFlo and Naturalyte contain another ingredient that the human liver converts to bicarbonate, causing a greater amount of bicarbonate in the body than other similar products. Because of this, GranuFlo and Naturalyte can create an overdose of bicarbonate in the body (metabolic alkalosis), which can cause cardiac arrhythmias, cardiac arrest and death in dialysis patients.
Because Fresenius is the largest dialysis treatment center operator in the United States, it became aware that GranuFlo and Naturalyte was causing heart attacks in its own dialysis patients. So on November 4, 2011, Fresenius distributed an internal memo to the doctors at its dialysis facilities. The internal memo stated that 941 patients had suffered heart attacks at Fresenius clinics in 2010. Fresenius found that patients with high levels of bicarbonate in their blood had about six times the risk of suffering a heart attack.
Despite knowing about the increased heart attack risk and the 941 deaths in its own facilities, Fresenius did not warn outside doctors and dialysis facilities that also use GranuFlo and Naturalyte.
In fact, Fresenius only sent out a warning in late March 2012 after the FDA anonymously received a copy of the internal memo and questioned Fresenius about it.
What should you do?
If you or someone you know has experienced heart arrhythmias, heart attack or other cardiac abnormalities during dialysis, you should immediately contact the attorneys at Hodes Milman Liebeck, LLP to find out about your rights. It is important your matter is immediately investigated.
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