GranuFlo Recall

Recently the FDA recalled a product called Granuflo. This product is used with dialysis patients routinely when they are having dialysis done. It contains sodium bicarbonate which neutralizes the build up of acid in the blood stream. The problem with Granuflo is that it contains more sodium bicarbonate that most other comparable drugs. As a result, the product can cause cardiac arrest and death due to a risk of potentially fatal serum bicarbonate levels found in the patients’ blood streams.

As if this news was not disturbing enough, the parent company behind the product Granuflo is Fresenius Medical Care. They are the largest dialysis company in the United States and the world and currently treat 1 out of every 3 patients on dialysis (over 120,00 people annually). They also manufacture nearly all the medical products used in dialysis. Fresenius Medical became aware of the drugs potential to cause cardiac arrest last year and sent out an internal memo to all of its clinics about the problem. They did not, however, notify any other clinics or the FDA, as required by law when any drug is found to be unsafe. Instead the memo that was sent out last year by Fresenius was anonymously leaked to FDA. The government agency then released an alert to all dialysis clinics about Granuflo and any similar products.  All clinics must now check patients’ bicarbonate levels prior to treatment.

Just how bad is the drug’s track record? Fresenius conducted a case control study of patients who had had cardiac arrest while getting dialysis at their clinics. 941 patient died from cardiac arrest in 2010

Because of Fresenius’ negligence, the result has been potential granuflo injury to many of the patients which have trusted their dialysis to this company and its products.  Once again exposing one of the problems with corporations driven by stock prices and profit instead of patient interest and health.

If you are currently getting or are planning on getting dialysis, please take the time to research who you are planning on using as your provider of dialysis services. Make sure they test their patients and you prior to the procedure, you do not want to have a heart attack because someone is taking a short cut. It is simply not worth your life and health deterioration to use clinic that doesn’t follow proper procedures.