Droperidol "Black Box" Warning
Revisited
The Food and Drug Administration (FDA) Anesthetic and Life
Support Drugs Advisory Committee will be meeting in Gaithersburg,
Maryland, on November 18, 2003, to discuss the issue of reported
cardiac risks associated with droperidol.
An ASA representative will be attending this meeting to express
the view that FDA's Black Box warning is unwarranted for the
doses of droperidol commonly used by anesthesiologists. We also
plan to make the point that the drug has been used for decades
by anesthesiologists without complications, and that the warning
has effectively removed one of the most efficacious drugs for
treatment of PONV for our patients.
ASA will utilize its Web site to keep its members posted on
this issue. The FDA meeting is open to the public. For more
information about the meeting, visit the FDA Web site at: http://www.fda.gov/oc/advisory/accalendar/cder12529dd11181903.html