The FDA has designated Fresenius Medical Care's ($FMS) relabeling of two dialysis products a Class I affair, warning that some patient populations risk cardiac arrest and death if given the treatments.
At issue are Frenesius' Naturalyte liquid and Granuflo dry acid concentrate, two renal failure treatments used with the company's dialysis machines. In March, Fresenius notified clinicians that the acetate or sodium diacetate in the two drugs could lead to a build-up of bicarbonate, and that could lead to cardiac arrest in patients undergoing hemodialysis.
Now, the German firm is in the process of relabeling the two treatments and updating the operator's manuals of its dialysis machines, Fresenius said in a statement, but the FDA is not requiring the company to pull either drug from the market. That said, the agency is taking the issue seriously enough to designate it a Class I recall, the FDA's most serious tag, as it noted current labels do not adequately warn of the serious dosing risks.
The company had already been in the FDA's crosshairs over its failure to fully disclose the above-mentioned issues with Granuflo. In November, Fresenius discovered the cardiac arrest risk of its treatment in patients with pre-existing high bicarbonate levels, The New York Times reported. The problem, however, is that the company only warned doctors at its own dialysis clinics, not disclosing the issue to outside physicians until March.
- read the FDA's notice
- here's Fresenius' statement