Federal drug regulators are warning health care providers to be more careful when prescribing drugs for dialysis patients, following reports of dosing errors during hemodialysis using dialysate concentrates containing acetic acid and acetate, which can lead serious and potentially life-threatening injury.
In a FDA safety communication issued on May 25, the FDA warned that dosing errors linked to NaturaLyte Liquid and Granuflo Acid Concentrate, as well as other dialysate concentrates, could cause serious problems for patients undergoing hemodialysis.
The procedure helps to clean the blood of wastes for patients suffering from kidney failure, but the drugs involved in the procedure contain acetic acid and acetate, which can increase the risk of cardiac arrest, low blood pressure, heart rhythm problems and chemical imbalances.
Acetic acid and acetates are used in hemodialysis dialysate concentrates. They are sources of alkali that, when metabolized, can raise bicarbonate levels in patients going through hemodialysis. This can lead to a condition known as metabolic alkatosis, which can increase the risk of death. The FDA warned that health care professionals may not be aware that the drugs they are using contain the alkali producers.
On March 29, Fresenius Medical Care, the makers of NaturaLyte Liquid, a dialysis acid concentrate, issued a prescribing information notice (PDF) to its customers, warning of the risk of bicarbonate alkalosis. In the notice, the company warns that analyses of hemodialysis patient safety data has linked alkalosis with increased risk of cardiac arrest and death, as well as extremely low potassium levels, a condition known as hyokalemia. The alkali amounts within the drugs should be factored into the total risk to the patient, the notice warns.
The FDA advised health care professionals to be aware that metabolic alkalosis has been linked to a higher risk of death in hemodialysis patients and to review the dialysis concentrate labeling for levels of acetate, acetic acid or citrate before writing the bicarbonate portion of a dialysate prescription. The FDA also recommended that they be sure to understand how a specific hemodialysis device mixes the acid and base concentrates and to discuss lab results with patients when appropriate.
The FDA says it worked with Fresenius on the prescribing notice and is continuing to evaluate adverse event reports and scientific studies on dialysates. The agency said it will inform the public of any future relevant information.