2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC114
Submitter : Ms. Elizabeth Kayser Date & Time: 11/01/2005 04:11:41
Organization : AANA
Category : Health Professional
Issue Areas/Comments
I am very concered that you propose to allow other than properly qualifed anesthesia providers to administer Propofol. I have been administering anesthesia for the last 36 years and can usually predict a patient's response to a given drug, but I am surprised on a daily basis with the idiosyncratic responses that patients make to known drugs. The ability to recognize that the patient is in respiratory distress is often a very subtle issue that only a qualified anesthesia provider can spot before the patient gets into real trouble. I can't remember the times I have been called down to a GI lab or other Non-OR setting to 'bail out' a patient that had been in serious respiratory distress for a significant period of time, before help was called for. PLEASE!!! DO NOT change the current caveat that specifies use of this drug should be ONLY by qualified General Anesthesia Providers, whose only responsibility is continuous monitoring of patient's sedation & repiratory status!