2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC184
Submitter : Dr. Zev Wachtel Date & Time: 12/13/2005 09:12:17
Organization : Dr. Zev Wachtel
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I have been performing sedation for over 20 years. This drug in most cases is very safe. However there are individual cases that require the expertise of a well trained Anesthesiologist or CRNA. I think that what the gastroenterologists want is to train RNs to perform a task that even a well trained anesthesiologist might find difficult. This will allow them to give a great drug for sedation in these type of cases. There have been some reports already circulating in the anesthesia journals that shows an increase in morbidity in the hands of trained RNs with this drug. I hope that what the FDA put into place years ago stands. I for one would never allow a family member to receive anesthesia from a RN with limited training.
Thanks Zev Wachtel M.D.