2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC144
Submitter : Dr. Lynn Mishkel Date & Time: 11/01/2005 04:11:59
Organization : Dr. Lynn Mishkel
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Patient response to propofol varies markedly and is unpredictable: I've used as little as 15 mg to as much as 340 mg to induce anesthesia; that is, loss of reflexes and obtundation. There is no reversal agent, the person administering the drug must be able to handle the probable, predictable, side affects of respiratory depression. Airway management is not to be left to untrained personel. It takes several years of training to be adept at this critical skill.
Lynn M Mishkel, MD
Anesthesiologist
Walker Baptist Mrdical Center
Jasper, Alabama