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FDA Upholds ASA Stance on Safe Use of Propofol

Thursday, August 19, 2010

In 2005, ASA submitted comments to and testified before the FDA opposing a Citizen Petition (Docket FDA-2005-P-0059) by the American College of Gastroenterology (ACG) asking that FDA remove the following language:

“For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectible Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.”

In a letter dated August 11, 2010, and made available on August 16, FDA denied the ACG petition in its entirety.

FDA summarized its reasoning as follows (page 2): "After considering your [petitioners'] claims and the literature you provided for our review, we conclude that you have not shown that the warning is no longer warranted or appropriate. In fact, we conclude that the warning is warranted and appropriate in light of the significant risks associated with propofol, and we further conclude that the warning should help ensure that propofol is used safely. Accordingly, we will not seek to have the warning removed, reduced, or otherwise amended."

The letter also references ASA, saying that the warning is consistent with recommendations of ASA, among others (see p. 7, p. 11, footnote 20). FDA also dispatched ACG's cost contention, saying that added costs associated with having an anesthesiologist administer the drug was warranted in light of the risks.

Finally, FDA concluded that the warning did not unduly restrict the practice of gastroenterology, mentioning that hospitals typically set their own procedures, but that in any event the warning was "appropriate and warranted in light of the significant risks associated with propofol."

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