2005P-0267
  

  
 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC20
  



  

  
Submitter : 
  

  
Dr. Ralph Glasser
  

  
Date & Time: 
  

  
08/25/2005 11:08:21
  



  

  
Organization : 
  

  
Dr. Ralph Glasser
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I wish to speak strongly AGAINST relaxing the standard of care for Propofol administration.



As an Anesthesiologist with 25 years practice in direct patient care, I have copious experience with drugs such as Propofol and its potentially adverse effects on patients.  



There is simply no valid argument for putting patients at increased risk by allowing them to receive this potent anesthetic without being cared for by a professional specifically trained in anesthetic care, airway management, resuscitation, hemodynamic management, and rescue.



Even trained professionals have had numerous occasions which require their expertise to prevent untoward patient outcomes.  To allow patients to undergo such a procedure, receiving potent anesthetics while monitored only by the operating physician and a non-anesthesia nurse would be subjecting the trusting public to an unnecessary risk.  People will die.



I urge you to consider the horrible consequences of such a misguided proposal and vehemently reject it.



Ralph Glasser, MD

Professor, Department of Anesthesiology

SIU School of Medicine