December 15, 2008
FDA Approves Fospropofol and Follows ASA’s Labeling Recommendation
ASA has learned that the FDA’s recent approval of fospropofol
disodium (brand name LUSEDRA) includes important safety information
recommended by ASA. The product’s labeling will help ensure the
highest standards of patient safety are maintained.
The safety information recommended by ASA and accepted by FDA reads:
Important Safety Information
LUSEDRA should be administered only by persons trained in the
administration of general anesthesia and not involved in the conduct of
the diagnostic or therapeutic procedure. Patients should be
continuously monitored during sedation and through the recovery process
for early signs of hypotension, apnea, airway obstruction, and/or
oxygen desaturation. Facilities for providing cardiopulmonary
resuscitation must be immediately available.
had previously submitted comments to the FDA outlining patient safety
concerns with the use of fospropofol and suggested appropriate warnings
for the package labeling. ASA member Thomas Henthorn, M.D., testified
similarly at an FDA advisory committee hearing on behalf of ASA.
ASA comment letter to FDA (April 2008)