Article, Emergency Medicine

After the black box warning: dramatic changes in ED use of droperidol


After the black box warning: dramatic changes in ED use of droperidolB

To the Editor,

Several recent articles and letters, both in AJEM and elsewhere, have commented on the propriety of the FDA black box warning on the use of droperidol [1-4]. As many emergency physicians believe that the drug’s dangers have been overstated, we sought to determine whether actual ED use has been affected. We distributed a 1-page survey to 260 attendees at the plenary session of a national Emergency Medicine meeting 10 months after the FDA warning was issued. Respondents answered questions regarding their use of droperidol and how the warning changed their practice. Responses were analyzed with Pearson’s chi-square.

A total of 207 surveys were returned, for an overall response rate of 80%. The majority of respondents, 69%, had more than 5 years experience; 82% worked in EDs with a census greater than 25K, and 42% in sites greater than 50K. Fully 97% of respondents were aware of the black box warning and 81% had changed their use of droperidol. Changes in droperidol use were unaffected by practice volume and years of experience. The drug had been remarkably popular; 73% had been using droperidol at least once a week, with 53% using it almost every shift. As a result of the warning, 71% of respondents now never use droperidol. Only 11% of those discontinuing droperidol cited patient Safety concerns; monitoring requirements and hospi- tal formulary discontinuation were both noted by 42%. For those still using droperidol, two thirds have not decreased the dose and only 12% now obtain a pretreatment 12-lead electrocardiogram; cardiac monitoring is used by 14% for varying periods. More than half (57%) of those changing their practice noted using ondansetron as an alternative for nausea/ vomiting, perhaps adding credence to the concerns voiced by

Mullins and Van Zwieten [1]. Of those using alternative Sedative agents (haloperidol, lorazepam, or ketamine), only 8% thought the alternative agent was more effective.

The changes in ED practice caused by the FDA-imposed black box warning [5] represent an excellent example of how clinical practice may be rapidly altered by regulatory action. Our findings demonstrate a dramatic change in ED practice largely unrelated to Clinical concern. Indeed, the vast majority of our respondents (92%) believed that their chosen alternatives were no more effective than droperidol; almost half (49%) thought the alternatives were worse. Our survey clearly indicates that the black box warning on droperidol has dramatically decreased its use in the ED, often to agents perceived to be less effective.


  1. Mullins ME, Van Zwieten K, et al. Unexpected Cardiovascular deaths are rare with Therapeutic doses of droperidol. Am J Emerg Med 2004;22:27 – 8.
  2. Zwieten K, Mullins ME, et al. Droperidol and the black box warning. Ann Emerg Med 2004;43(1):139 – 40.
  3. Meyer RJ. FDA bblack boxQ labeling. Ann Emerg Med 2003;41:559 – 60.
  4. Lenzer J, Solomon RC. The droperidol dilemma: is the FDA’s black box warning necessary? ACEP News 2002;3,8.
  5. Inapsine (droperidol injection), black box warning, Taylor Pharma- ceuticals, and Akorn Co, 11/01.

Jeanne L. Jacoby MD Jessica Fulton DO Mark Cesta MD Michael Heller MD

Emergency Medicine Residency

St. Luke’s Hospital Bethlehem, PA 18015, USA

E-mail address: [email protected]

B No outside funding was received.

0735-6757/$ – see front matter D 2005 doi:10.1016/j.ajem.2004.09.019

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