As of this writing, anesthesiologists have been living with the “black box” warning (or the “boxed warning” in FDA parlance) for droperidol for over two years. The response by clinicians and institutions has ranged from little change in practice (as in my own institution) to complete removal from the formulary. Clinicians who have described in letters to the editor or public lectures abandoning droperidol usually give as the reason their concerns about the liability of continuing to use a drug with a boxed warning. In addition, these writers and speakers (including myself) have castigated the FDA for taking too drastic an action without adequate supporting data.

It is clear to me that, although the FDA was successful in informing anesthesiologists about the change in the droperidol label, including the boxed warning, they were quite unsuccessful in explaining why they took the action they did. For example, it was not until November 18, 2003 that the FDA held a meeting with anesthesiologists to discuss droperidol safety. At this meeting of the Anesthetic and Life Support Drugs Advisory Committee, one of the Human Drug Advisory Committees within the Center for Drug Evaluation and Research, the attendees were charged by the FDA with recommending what was currently known about the safety of droperidol and what studies should be done to remedy the gaps in knowledge. The minutes and transcript of this meeting are major sources for this article.