May 14, 2008
A new anesthetic agent that might inspire more gastroenterologists and other physicians to administer deep sedation themselves is soon going to be on the market. A panel of the Food and Drug Administration (FDA) recommended approval of Aquavan (fospropofol bisodium) on May 7, 2007. The panel is to be commended for voting 9-1 against the use of fospropofol by nonanesthesiologists, following testimony by the American Society of Anesthesiologists (ASA).
The manufacturer, Japan’s Eisai Company, Ltd. has been advertising the new drug claiming that it can be administered by nonanesthesiologists, unlike propofol itself. Aetna alluded to fospropofol when it withdrew its plan to stop paying anesthesiologists for providing sedation for patients undergoing GI endoscopies earlier this year, hinting that the new drug would make it easier for gastroenterologists to sedate their patients on their own. On April 18, the American Gastroenterologic Association (AGA) Institute’s president wrote a letter to the FDA’s Anesthetic and Life Support Drug Advisory Committee urging approval of new sedation options for colonoscopy and their use by “properly trained gastroenterologists.”
On April 23, ASA filed formal “comments” with the FDA Committee, just as it had in 2005 when the gastroenterologists sought removal of the “black box warning” on propofol, which continues to read that the drug “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Patients should be continuously monitored, and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available.” ASA strongly believes that fospropofol should be packaged with the same warning, and provided numerous reasons both in the letter signed by President Jeffrey L. Apfelbaum, M.D. and in oral testimony before the FDA panel by Dr. Thomas Henthorn, Professor and Chair of the Department of Anesthesiology at the University of Colorado.
The FDA’s decisions both on the approval of Aquavan and on any warning labels that might be required are expected on July 26. On behalf of our clients, the large majority of whom are ASA members, we thank ASA for its continued vigilance and protection of patient safety.