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.

 ASA 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)