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Fresenius Waited Months Before Warning Doctors of GranuFlo Danger, New York Times Reports

The FDA launched an investigation of Fresenius (which runs the country’s largest network of kidney dialysis centers) because Fresenius initially warned only doctors in its own network about the risk of dosage mistakes in its acid concentrate products GranuFlo and NaturaLyte, but did not warn doctors outside its network until four months later, knowingly putting patients outside its network at risk of an overdose, a New York Times article reports.

Products could cause bicarbonate overdose

According to the New York Times article, published on June 14, 2012, the FDA had anonymously received a copy of an internal Fresenius memo dated November 4, 2011 that noted that physicians were unaware that GranuFlo and NaturaLyte had the potential to elevate bicarbonate levels in patient’s bodies more than other concentrates. Because of this lack of knowledge, the physicians were not properly adjusting the dosage for the products, which could result in an overdose of bicarbonate and potentially lead to a pH imbalance known as metabolic alkalosis, which can cause arrhythmias, high blood pressure, heart attacks, or death.

The memo also noted that in its own case-control study, researchers found an elevated level of bicarbonate in the blood of 941 patients who died of cardiac arrest in Fresenius dialysis centers in 2010, and that an elevated level of bicarbonate in the blood was an independent risk factor for cardiovascular side effects.

Fresenius sent the memo to physicians in its network of dialysis centers, warning them about the risk of dosage mistakes and potential side effects from GranuFlo and NaturaLyte, but did not warn physicians in dialysis centers outside its network, even though those doctors also used GranuFlo and NaturaLyte.

Only after the FDA anonymously received the memo and questioned Fresenius about it did the company finally issue a warning to other dialysis centers, medical centers, and nursing homes in March 2012 – four months after warning its own doctors.

In the New York Times article, Fresenius North American chief medical officer Dr. Franklin W. Maddux defended his office, which had written the memo, saying that his office did not have any way of contacting non-Fresenius medical centers aside from papers in medical journals, and that the results of the case study were too preliminary to publish.

FDA recalled GranuFlo and NaturaLyte in June 2012

On May 25, 2012, the FDA issued a warning to the medical community about the risk of dosing errors when using GranuFlo and NaturaLyte in dialysis. This warning was followed a month later by the FDA recall of the medication GranuFlo and NaturaLyte on June 27, 2012. In issuing the recall, the FDA stated that the medications “may cause serious adverse health consequences, including death.”

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