Category: fda

Permission granted, but not for all.


After much wrangling on anesthesia safety and labeling the propofol pro-drug fospropofol has been approved by the FDA.  

Fospropofol is a water-soluble prodrug of propofol, metabolized by the liver altering the pharmacokinetics to produce a slower peak effect and longer duration.  All of the problems associated with the lipid emulsion are assumed to be null and void with this formulation (pain on injection, bacterial contamination, hyperlipidemia etc..).
Fospropofol was designed for procedural sedation and was championed by the endoscopists as a “safer” alternative to propofol.  Thanks to the ASA’s stern warning letter to the FDA, the labeling requiring the presence of an anesthesia provider remains, and the safety of patients having their insides examined remains with us.
No info on when it’ll be ours for the sedating.