Granuflo Recall news

The Merman Law Firm is now accepting Granuflo cardiac arrest cases nationwide.

Granuflo, manufactured by dialysis giant Fresenius, is a product used in dialysis treatments. Granuflo acts as a precursor to the body’s bicarbonate production that significantly increases bicarbonate content in the body.   This bicarbonate level is crucial throughout the dialysis process.  Doctors need to prescribe the right level of bicarbonate to dialysis patients because either too much or too little can have catastrophic results that include: metabolic alkalosis, which is associated with low blood pressure, hypercapnia, hypokalemia, hypoxemia, and cardiac arrhythmia. Often these conditions lead quickly to cardiopulmonary arrest and death.

Fresenius, which manufactures and distributes Granuflo and NaturaLyte, discovered in November of 2011 that doctors prescribing Granuflo had the wrong information about how much Granuflo increases a patient’s pre-dialysis bicarbonate levels.  As a result, patients getting Granuflo typically had too much bicarbonate in their blood and developed acute alkalosis.  This elevated bicarbonate made patients  6 to 8 times more likely to have sudden cardiac arrest and cardiac death in the dialysis facility.  More than 900 patients in Fresenius dialysis facilities suffered cardiac arrest in 2010 alone.  Fresenius decided to warn its own doctors and patients of the life-threatening situation, but did not warn the 125,000 other dialysis patients using its product!

Fresenius determined that “in light of these troubling findings,” physicians at Fresenius centers be urgently warned so they could adjust the dialysis settings to compensate for the increased bicarbonate in Granuflo.   Fresenius, however, did not alert the physicians at any non-Fresenius facilities that were using Granuflo.  The result was that more than 100,000 patientis continued using Granuflo unaware of the levels of bicarbonate it contained or the serious problems it could cause.

Finally in March of 2012, the FDA stepped in and initiated a Class I recall of Granuflo because it had the potential to cause serious health effects and death.  A Class I recall is the most serious recall issued by the FDA.

If you or someone you know suffered a cardiac event at a dialysis facility after using Granuflo or NaturaLyte, you need a serious drug defect attorney.  The Merman Law Firm can help you recover for the loss caused by this dangerous product.