A Class I recall for the dialysis concentrates of Granuflo and Naturalyte was issued March 29, 2012 by the Food and Drug Administration (FDA) due to the increased risk for cardiac arrest when inappropriately prescribed. The recalled drugs are used during hemodialysis to treat acute and chronic renal failure. The FDA is looking into whether the potentially lethal risks connected with Granuflo and Naturalyte should have been shared with hemodialysis patients by Fresenius Medical Care.
When inappropriately prescribed, Granuflo and Naturalyte have the potential to cause:
- Cardiopulmonary arrest
- Cardiovascular death
- Catastrophic cardiovascular injuries
- Congestive heart failure
- Heart attack
- Sudden cardiac death
The New York Times reports that an internal memorandum was sent to Fresenius’ dialysis center doctors November 4, 2011 warning them of the extreme cardiac risk and likelihood of death linked to improper administration of these drugs.
Bicarbonate levels are important to hemodialysis, because they supply the patient with alkaline to neutralize acids in blood being filtered of waste, extra salt and water by the machine. Granuflo and Naturalyte each contain bicarbonate, but doctors have not been allowing for the built-in bicarbonate in prescribing the drugs thereby overdosing patients with bicarbonate.
High bicarbonate levels, according to the FDA, can create a significant risk factor for dialysis patients by contributing to a metabolic condition:
- Cardiac arrhythmia
- High concentration of carbon dioxide in the blood
- Low blood oxygen pressure
- Low blood pressure
- Low potassium levels in the blood
In addition to the recall, the FDA issued a technical reminder to medical professionals within the nephrology specialty area regarding “acetate, acetic acid and/or citrate levels in dialysate concentrates and the need to consider the impact of these substances when ordering or administering the patient’s dialysate prescription.”
Fresenius is the largest operator of hemodialysis centers in the United States, treating one-third of the nation’s estimated 400,000 hemodialysis patients. Numerous clinics not operated by Fresenius additionally use disposable products and hemodialysis machines supplied by the company.
Please contact a licensed attorney experienced in medical malpractice and product liability if you, or a loved one, have suffered harmful effects due to the administration of Granuflo and Naturalyte.