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Fresenius, GranuFlo, and NaturaLyte: An Overview

With the recent FDA recall of the medication GranuFlo and NaturaLyte, it’s a good time to look back at how this recall came to pass.

Fresenius Medical Care is a German-based company that runs the largest network of dialysis centers in North America, treating as many as one-third of the 400,000 dialysis patients in the United States. The company also provides on-site dialysis service in more than 1,000 hospitals and partner clinics, treating an estimated 125,000 additional patients. In addition, Fresenius manufactured two acid concentrates that were used in dialysis: GranuFlo and NaturaLyte. These medications were used not only in Fresenius’ own dialysis centers, but also in many medical centers and nursing homes around the U.S.

Heart attack risk from GranuFlo and NaturaLyte

In November 2011, Fresenius sent an internal memo to doctors in its own network of dialysis centers, warning that using GranuFlo in dialysis raised bicarbonate levels in patients’ blood, which could result in a condition known as metabolic alkalosis, which in turn could cause cardiovascular problems including arrhythmias, heart attack, or death. In order to prevent this risk, it was vitally important for doctors to properly adjust the dosage given of the medication. The memo also noted that Fresenius’ own case-control study found that 941 patients who had died of a heart attack after using GranuFlo in its dialysis centers had had elevated blood levels of bicarbonate, a risk factor for heart attack.

However, while Fresenius warned doctors in its own dialysis centers of this risk, it did not send the memo to the rest of its customer base of medical centers and nursing homes that used GranuFlo and NaturaLyte for dialysis. Patients undergoing dialysis at those centers were still at risk of bicarbonate overdose, because their doctors weren’t aware of the risk.

In March 2012, the FDA was anonymously sent a copy of the November internal memo, and launched an investigation into Fresenius to find out why it had failed to warn outside doctors of its products’ risks. In response, Fresenius finally did warn the rest of its customers, four months after warning its own doctors.

Recall of GranuFlo and NaturaLyte

On June 27, 2012, the agency issued a Class 1 FDA recall of the medication GranuFlo and NaturaLyte. A Class 1 recall is the highest level of FDA recall, indicating the greatest urgency and the possibility of extreme danger associated with the recalled product. In issuing the recall, the FDA stated that the medications “may cause serious adverse health consequences, including death.”

Patients who were unnecessarily exposed to risk of side effects from these medications may have grounds for a GranuFlo lawsuit. Depending on the number of lawsuits filed, a class action lawsuit or multidistrict litigation could be established in future.

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