2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC131
Submitter : Dr. Nizam Meah Date & Time: 11/01/2005 04:11:51
Organization : Digestive
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Dear Sirs:
The issues surrounding the use of Propofol by Non-anesthesiologists is only one and it is safety. In the span of more than last 5 years and hundreds of studies involving thousands of patients in many different parts of the world, it is beyond doubt that Propofol could be very safely used in endoscopic sedation by the people who are used to use sedation with other conventional agents. It has been true universally both in academic and nonacademic private practice setting. If there were no monetary reward for administering this agent by non-endoscopists, it would have been a non-issue by now. Reserving the monopoly of this particular medicine with proven safety and efficacy will be a disservice to our consumers who are having to pay for the cost of unnecessary anesthesia service in majority of endoscopic services.
One argument put forward in Propofol issue is that it has no reversal agent. But propofol effect is mitigated in the human body so rapidly that even if a reversal agent were there, it will be impractical to use it. By the time you take the reversal agent in a syringe and flush in IV, the effect of Propofol effect would be over. A sedation agent is needed for narcotic agents and sedatives that are being used now as conventional agents since they have much longer half life compared to Propofol. Therefore, from this perspective Propofol is even safer than conventional agents, in deed this should be another reason to not to reserve it only for the anesthesia personnels.
In my own experience, I have found that Propofol is safer than conventional agents especially in patients who need high dose of nacotics and sedatives. An example of this will be, patients with Chronic Pain Syndrome and patients on Psychotropic medications. In these cases only a very small dose of Propofol does the trick. IN deed, in these cases an expert sedationist uses the Hypnotic effect of Propofol rather than the anesthesia effect of it. IT is not at all surprising for we know that Propofol is the strongest usable hypnotic agent we have now.
Another argument is that Propofol is "Anesthesia Agent". This argument has no scientific basis at all. For all the current agents like Versed(Midazolam), Demerol and Fentanyl are also Anesthesia agents. The "Anesthesia agents" are so subjective that each hospital anesthesia group has its own list of agents. It is the trained physician who decides what dose to use, any of these agents are anesthesia agent in adequate dosage. Our colleagues need to realize that they use Anesthesia dose for all of these agents and we as Gastroenterologists, use sedation dose, not the anesthesia dose.
Lastly, I petition that FDA takes that action of approptiately deleting the warning that Propofol should only be used by only Anesthesiologits. FDA should act in favor of public and science based on the proven studies. IT is not FDA's job to protect monolopy of a specific specialty on specific drug while data is on the contrary. Thank you.
Respectfully submitted,

Nizam M. Meah, MD
109 Parking Way
Lake Jackson, TX 77566
979 292 0033