Dialysis Company Failure to Notify FDA of Product's Serious Problems

The most commonly prescribed dry acid product in the dialysis industry today is the Granuflo, which is made by Fresenius Medical Care (FMC). Granuflo with sodium diacetate had been approved for marketing by the Food and Drug Administration (FDA) in 2003. In the United States, there are more than 5700 dialysis center and above 400,000 dialysis patients. About 3300 clinics and 260,000 patients have been known to use this product. Yet, the product has received negative reviews.


Fresenius is considered to be the largest dialysis services and product worldwide that utilize this formulation in its clinic to help victims of kidney failure with dialysis care. When it was discovered that sodium diacetate was the root cause of a series of medical emergencies, some resulting in death, FMC product executives finally elected to inform managers and physicians at Fresenius’ dialysis clinics of the problem.


However, the Fresenius executives in product manufacturing took 16 months to make a two-page memo in response to an FDA inquiry. It was not included in the memo, dated March 27, 2012, that patients need to be aware of its high risk of kidney failure and high pre-dialysis serum bicarbonate levels which create risk for cardiac arrest and death.


Stern fines and penalties, including being banned from selling products for use in facilities that treat Medicare patients, are the punishments for the company that fails to notify the FDA of a known problem with an FDA-approved medical device.


The increasing number of deaths have been attributed to this acid concentrate. The many complications brought about by Granuflo has made the FDA believed that the company has not been truly transparent. To know more about the GrabuFlo recall check the Granuflo Lawsuit Center for more information.


References:

nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0

fmcna-concentrates.com/acid_acetic_granuflo.html

allnurses.com/dialysis-renal-urology/fresenius-granuflo-were-715586.html