FDA Probes Dialysis Company Over Failure to Warn of Product Risk

The U.S. Food and Drug Administration is probing Fresenius Medical Care – the nation’s largest operator of dialysis centers – to determine if it violated federal regulations by not informing the public of a possibly deadly risk linked to one of its products.

In November 2011, Fresenius sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that improper use of its GranuFlo product appeared to be contributing to an increased risk of patient death from cardiac arrest and urging corrective action, according to The New York Times.

However, the company did not initially share this warning with other clinics that use the product until the FDA received a copy of the memo and began making inquiries. An estimated 125,000 patients are treated with GranuFlo in clinics not associated with Fresenius.

GranuFlo, used in dialysis, contains an ingredient that the body converts to bicarbonate and it has more of this ingredient than similar products, according to the Times. Some doctors may not be taking this increased amount of bicarbonate into consideration when separately writing a patient’s prescription for bicarbonate. This can lead to an overdose, which could cause serious heart issues.

The memo from Fresenius found that 941 patients suffered cardiac arrest at its clinics since 2010.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you. For legal help, call (800) 581-6358.

Tags: