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A Class I Recall of Granuflo is Issued When a Fresenius Internal Memo About Heart Attacks and Death is Discovered

Granuflo is a dialysis product manufactured by the German company Fresenius. The product is administered while patients are undergoing dialysis and contains ingredients that convert to bicarbonate when mixed with other substances. This is necessary to clean waste from the blood during dialysis treatment.

Concerns of heart attacks have resulted in the FDA issuing a Class I recall of Granuflo. Many of those affected by issues with the product have filed Granuflo lawsuits due to the death or injuries to themselves or loved ones.

Following the recall, the number of lawsuits against Granuflo rose and may increase even more. The recall did not remove the product from the market, but instead, stronger warnings were issued on the product label about proper dosing amounts and cautioning doctors to be use extra care.

Studies show a six-fold increase in risk of Granuflo heart attack with Fresenius products

Too much bicarbonate can lead to overdose and heart attack or death. Studies show that Fresenius products such as Granuflo can risk a heart attack by six-fold. For patients who showed elevated bicarbonate levels pre-dialysis and those who were “acute” patients and had what is known as acute kidney failure, the risks were greater.

Another risk factor for heart attack or death is metabolic alkalosis. Metabolic alkalosis is characterized by cardiac arrhythmias, low blood pressure, and low blood oxygen.

The lawsuits have yet to be coordinated, but as the number of them rises, the chance of a mass tort or MDL will increase along with the number of filings in order to streamline the proceedings.

Fresenius notes as many as 941 deaths were linked with Granuflo in 2010

The recall was spurred after an internal memo was leaked to the FDA. In the November 2011 dated memo, Fresensius acknowledged as many as 941 incidences of Granuflo death were connected to the incorrect dosages of Granuflo being administered in 2010 alone. As patients realized they had received the wrong dosages and the risks involved, these Granuflo side effects led to many lawsuits being filed. Fresenius chose not to share the memo with non-Fresenius clinics that use Granuflo.

The FDA investigated Fresenius when they learned of the memo and after a few months, the Class I recall—the most serious type—was issued. It warned that doctors were prescribing the wrong dosage of Granuflo and there were a higher-than-average number of injured patients.

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