2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC155
Submitter : Dr. Silver Dwinell Date & Time: 11/17/2005 01:11:27
Organization : Dr. Silver Dwinell
Category : Health Professional
Issue Areas/Comments
I believe it is unsafe and inappropriate for any professional to self-administer or supervise administration of Propofol if they are not fully trained in the administration of General Anesthesia. Those administering this drug must be able to quickly, safely, and intelligently resolve and/or deal with possible complications of medication overdose, the two most deleterious being apnea and risk of pulmonary aspiration of gastric contents. The patients safety must not be sacrificed for the all-powerful dollar (see document arguement for decreased cost to insurer/patient). As medical professionals we have a responsibility to provide the best and safest care to all patients, and as a trained anesthesiologist who has seen the negative consequences of medication overdose, I can assure you that approval of the proposed document is a relegation of this responsibilty by our community.