The FDA investigated Fresenius Medical after more than 900 patients experienced heart attacks at the company’s in-house dialysis centers,according to a Fresenius memo that wasn’t given to Fresenius dialysis patients.
The FDA began its investigation after a dialysis website leaked a copy of an internal memo released to the company’s in-house dialysis centers. The memo disclosed adverse events possibly associated with the use of its Granuflo dialysis concentrate, including a possible 5-time increase in heart-attack risk associated with the compound.
According to the memo, more than 900 patients suffered sudden cardiac arrest at Fresenius dialysis clinics in 2010. Researchers found that patients with elevated levels of bicarbonate in the blood were five times more likely to suffer an attack. According to the memo, Fresenius Medical Center was already aware of a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with their Granuflo and NaturaLyte dialysis concentrate products containing sodium diacetate. The memo recommended action for patients with elevated pre-dialysis bicarbonate levels. Fresenius Medical Center only provided this memo to their doctors and dialysis facilities – not to non-facility physicians and clinics that were using products, despite the fact that over 100,000 dialysis patients were receiving these products at non-Fresenius Medical Center facilities.
The Granuflo product contains a compound that creates bicarbonate to help reduce acidity in the blood. Because Granuflo contains a higher concentration of that compound than similar products, doctors must modify the standard bicarbonate prescriptions given to patients for outside-the-clinic use. Patients who receive the standard bicarbonate dose may experience excessive amounts of bicarbonate in their blood, potentially causing metabolic alkalosis, which can lead to low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia – all of which can culminate in cardiopulmonary arrest (heart attack) and death.
Currently, there are more than 5,700 dialysis centers providing service to about 400,000 dialysis patients in the U.S. Fresenius Medical Center, the largest dialysis services and products company in the world, not only owns thousands of dialysis clinics, but it also manufactures nearly all of the medical products used in dialysis care.
After receiving a copy of the November 4th internal memo, the FDA forced Fresenius Medical Center executives to issue an urgent public product warning and recall to its customers advising which GranuFlo® and NaturaLyte® products were associated with elevated bicarbonate levels and an increased risk for cardiopulmonary arrest and sudden cardiac death.
There have been 941 deaths reported so far. Fresenius Medical Center conducted a case-control study that evaluated the risk factors in hemodialsis patients who suffered from cardiopulmonary arrest in Fresenius facilities compared to other dialysis patients within the same facilities between January 1, 2010 – December 31, 2010. During this time, 941 patients in 667 Fresenius Medical Center facilities had cardiopulmonary arrests within those facilities. Looking at the data for these 941 patients, the study further found that the patents’ risk of cardiopulmonary arrest was up to six times higher if they had an elevated pre-dialysis bicarbonate level.
The Shelton Law Group is currently investigating and pursuing Granuflo® and NaturaLyte® dialysis product claims. If you or a loved one believes you or they have suffered a heart attack or other adverse health effects as a result of using these products, then contact the Shelton Law Group now at 1-888-761-7204 or visit www.robsheltonlaw.com. We take your case personally.