Dangers of Increased Cardiac Arrest in Dialysis Patients
Thousands of people have had cardiac complications related to use of Granuflo and Naturalyte while undergoing dialysis. The high incident of cardiac death in Fresenius facilities prompted Fresenius to issue an internal memorandum directing its doctors to modify Granuflo dosages to account for high-than-expected bicarbonate levels in patients receiving Granuflo and Naturalyte. Fresenius did not warn doctors using their product that did not work at Fresenius facilities. As a result, more than an estimated 125,000 patients continued to receive incorrect dosages of bicarbonate (from Granuflo and Naturalyte) before the FDA received a copy of the Fresenius internal memorandum. Once the FDA recieved information that using Granuflo as recommended by Fresenius resulted in cariac arrests six to eight times more frequently than when it was used correctly, the FDA issued a Class I recall of Granuflo. Class I is the most serious recall, reserved for products that have a potential to cause serious heath issues and death.
It is not new news that cardiac events happen more often during dialysis than the typical averages. This issue has received a lot of attention over the last decade. In fact, a comprehesive study of Fresenius patients suffering cardiac arrests was performed in 1999. That study, published in Nature, determined that almost 20% of patients suffering cardiac events had received a bicarbonate precursor. The scientists studying this issue found that, “Among the 400 case patients presented here, 17.8% were dialyzed against a low dialysate potassium concentration (0 or 1.0 mEq/L), and in fewer than one in five was the most recent serum potassium 5.0 mEq/L. In addition to the development of dialysis-induced hypokalemia, more subtle metabolic abnormalities might also place patients at increased risk of arrhythmia.” http://www.nature.com/ki/journal/v60/n1/full/4492407a.html
Fresenius knew or should have known that bicarbonate levels, both low and high, had a significant impact on cardiac arrests in dialysis patients. Once it learned of this fact, it directed its own doctors to modify their use of Granuflo. Fresenius could have saved many more lives if it had warned doctors sooner of the dangers of using Granuflo as directed and if it had chosen to warn doctors other than its own once it was satisfied of the link between Granuflo and cardiac arrest.