The FDA recalled Granuflo (manufactured by Fresenius) on March 29, 2012, because it has been linked to cardiac arrest and death in dialysis facilities; a Granuflo lawsuit has already been initiated. The Merman Law Firm is tracking the Granuflo Lawsuit on its blog, as well as providing information to consumers regarding why Granuflo proved deadly to some dialysis patients.
What is Granuflo?
Granuflo and its sister product NaturaLyte are products used in dialysis treatments to combat high acid content that frequently accompanies dialysis. Granuflo acts as a precursor in the body’s bicarbonate production system 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 six to eight 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, according to an internal memo at Fresenius that was leaked to the FDA. Fresenius did not warn other facilities using its product of the dangers.
Following the 940 cardiac arrests in 2010 in Fresenius facilities, Fresenius linked Granuflo to cardiac arrests during dialysis. 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 hundreds, if not thousands, of doctors, continued using Granuflo unaware of the levels of bicarbonate it contained or the serious problems it could cause. RenalWEB estimated that 125,000 patients in non-Fresenius facilities are treated with Granuflo.
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. Fresenius claimed that, although it had enough information to warn the doctors in its own facilities, it did not feel the need to warn other doctors using the product during dialysis at other facilities. Dr. Franklin Maddux, chief medical officer for Fresenius North America stated in an interview that the memo's findings were "not in a condition for general consumption."
Fresenius knew that its product was dangerous and warned its doctors. It chose not to warn the doctors of the other 125,000 patients using its product in dialysis. Those patients did not learn of the dangers of using Granuflo until the FDA Class I recall.
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.