2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC16
Submitter : Dr. Keith Chamberlin Date & Time: 08/25/2005 11:08:21
Organization : ACM, Inc.
Category : Health Professional
Issue Areas/Comments
Propofol is an extemely potent and dangerous medication. Much like Midazolam when it was first released, the side effects are apnea and hypotension. Again, just like Midazolam, (where a number of fatal overdoses were seen in gastroenterologists offices) use of propofol by non anesthesia trained providers will result in similar disasters.

It is imperative to protect patients from unsafe use of potent medications. Propofol is a general anesthetic - and the dosage is very variable among patients. Safety dicatates is be administered only by anesthesia providers.

Thank you