The New York Times reports that the company is the country’s number-one provider of dialysis machines and related products. Fresenius also has many of its own dialysis clinics that serve large numbers of Americans.
The U.S. Food and Drug Administration is looking into how Fresenius handled its discovery that one of its dialysis products may have been the agent involved in a high number of heart-attack deaths of dialysis patients. The federal drug regulatory agency questions whether Fresenius adequately complied with federal warning and information-sharing requirements for dangerous drugs.
The issue concerns Fresenius’ dialysis drug GranuFlo that contains a relatively high level of a substance that chemically changes to bicarbonate in the body. Bicarbonate may be separately prescribed for kidney-dialysis patients to neutralize acid in the blood. Allegedly, some prescribing physicians had not been lowering those prescription levels in light of the extra bicarbonate being generated by GranuFlo in the same patients.
And high levels of bicarbonate have been linked to heart conditions.
Fresenius issued an internal memo in November 2011 warning its own clinical staff of a possible link between GranuFlo and heart attacks. Fresenius had had 941 of its own clinic patients suffer cardiac arrest on clinic premises in 2010 and they were determined to have had enough extra bicarbonate in their systems to raise their risk of cardiac arrest by approximately six times.
In March 2012, the internal Fresenius memo was anonymously leaked to the FDA, which raised the question why the company had not also warned its non-Fresenius clinical customers of the danger from GranuFlo and a similar product, NaturaLyte Liquid. Almost immediately, the company issued an urgent product notification of the risk to its customers and other medical professionals who might have reason to use the drugs.
At about the same time, GranuFlo became the object of an FDA Class I recall, the most urgent level. The FDA followed up in May 2012 with a broader safety communication detailing the potential danger of using these and similar products without accounting for the extra bicarbonate produced in the body when writing other bicarbonate prescriptions.
Safety advocates anticipate with interest the result of the FDA investigation into Fresenius’ actions.
Source: The New York Times, “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” Andrew Pollack, June 14, 2012