2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC100
Submitter : Mr. Anthony Guglielmi Date & Time: 10/13/2005 11:10:49
Organization : Mr. Anthony Guglielmi
Category : Individual Consumer
Issue Areas/Comments
As a non-healthcare provider, I have grave concerns with the patient safety risks associated with this label change. It is my understanding that propofol is a sedative agent that does not have any reversal medications. According to the current drug label, along with rendering a patient unconscious for surgery, this drug has the ability to cause respiratory depression. What is the benefit to removing individuals trained in anesthesiology from this equasion? Are we putting dollars before patient safety?

I think America and the FDA learned a valuable lesson from the recent Vioxx tragedies. Perhaps if that drug had stronger labeling, lives could have been saved. I urge this committee to fully evaluate the pros and cons of this label change and make a determination that is in the best interest of patient safety and qulaity of care.

Anthony J. Guglielmi,
Rocky Hill, CT.