Cytosol Laboratories
This article was originally published in The Gray Sheet
Executive Summary
FDA urges hospital pharmacies and hemodialysis units to stop using the firm's triCitrasol, a 46.7% concentration of sodium citrate for use as a dialysis catheter anticoagulant, in an April 14 Talk Paper. The warning follows the death of a patient from a "full strength" injection of the unapproved product into a hemodialysis permanent blood access catheter that had just been implanted. The product "can cause fatal heart rhythm disruption, seizures or bleeding due to loss of blood calcium," according to FDA